study for the european commission on ‘possible ways to

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1 Study for the European Commission on ‘Possible Ways to Address Digital Sequence Information Legal and Policy Aspects’ Consultancy project conducted for the European Commission: ENV.F.3/SER/2019/6175145 Prof Elisa Morgera, Dr Stephanie Switzer, Miranda Geelhoed, LLM December 2019 (revised: March 2020; July 2020; August 2020) Strathclyde Centre for Environmental Law and Governance (SCELG) Lord Hope Building 141 St James Road Glasgow G4 0LT

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1

Study for the European Commission on ‘Possible Ways to Address Digital Sequence

Information – Legal and Policy Aspects’

Consultancy project conducted for the European Commission: ENV.F.3/SER/2019/6175145

Prof Elisa Morgera, Dr Stephanie Switzer, Miranda Geelhoed, LLM

December 2019 (revised: March 2020; July 2020; August 2020)

Strathclyde Centre for Environmental

Law and Governance (SCELG)

Lord Hope Building

141 St James Road

Glasgow

G4 0LT

2

Contents

List of Acronyms ................................................................................................................... 4

Introduction ............................................................................................................................ 6

a) Methodology and scope ........................................................................................... 7

b) Core assumptions and summary of findings ............................................................ 8

Option 1: DSI is not covered by the CBD or the Nagoya Protocol ..................................... 12

a) The conceptual underpinnings of the debate over whether DSI comes within the

scope of the CBD and Nagoya Protocol .......................................................................... 12

b) A legal and policy basis analysis of the inclusion of DSI with the CBD and Nagoya

Protocol ............................................................................................................................ 13

Option 2: DSI is covered by the CBD and the Nagoya Protocol: benefits from use of DSI

are to be included in MAT and no additional measures are taken ....................................... 15

Option 3: The current system is complemented by a new track-and-trace system .............. 16

a) Background ............................................................................................................ 16

b) Retracing of information ....................................................................................... 16

c) Blockchain ............................................................................................................. 19

d) Improved track-and-trace as part of a hybrid approach ......................................... 21

Option 4: A sui generis system inspired by copyright ......................................................... 23

a) Copyright in broad terms ....................................................................................... 23

b) DSI and copyright – understanding the context .................................................... 24

c) Reimagining copyright protection? ....................................................................... 25

d) The benefit of a sui generis system inspired by copyright: the example of annotation?

.......................................................................................................................................... 26

f) A broader system encompassing the range of actors along the DSI value chain? .... 28

g) Operationalisation .................................................................................................. 30

h) States’ rights under a domaine public payant model ............................................. 31

Option 5: A multilateral fund ............................................................................................... 35

a) Funding – accrual of benefits ................................................................................ 36

b) Funding – disbursement of benefits....................................................................... 42

c) Governance, accountability and decision making ................................................. 46

d) Sites of governance ................................................................................................ 49

Option 6: A multilateral platform for benefit-sharing ......................................................... 53

a) Beyond monetary and non-monetary benefits ....................................................... 53

b) Taking inspiration from the governance of the GLIS: tackling the issue ‘from the

side’ 54

c) Facilitating and brokering scientific cooperation and capacity-building .............. 56

d) In conclusion: a multilateral multifunctional platform on DSI ............................. 57

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Option 7: Hybrid approach .................................................................................................. 59

a) An overview .......................................................................................................... 59

b) Opearationalizing the digital domaine public payant as part of the platform ...... 60

c) The centrality of the CBD ..................................................................................... 64

Conclusion ........................................................................................................................... 67

Annex Table: Overview of Six Existing Multilateral or Global Funding Mechanisms ...... 69

4

List of Acronyms

ABS access and benefit-sharing

AHTEG Ad Hoc Technical Expert Group

AN Accession Number

BBNJ biological diversity of areas beyond national jurisdiction

BSF Benefit-Sharing Fund

CBD Convention on Biological Diversity

COP Conference of the Parties

COP-MOP Conference of the Parties serving as the Meetings of the Parties

DNA deoxyribonucleic acid

DOI Digital Object Identifiers

DSI digital sequence information

EU European Union

FAO Food and Agriculture Organization of the United Nations

GAFSP Global Agriculture and Food Security Program

Gavi Global Alliance for Vaccines and Immunisation

GCF Green Climate Fund

GDPR General Data Protection Regulation

GEF The Global Environment Facility

GFATM The Global Fund to Fight AIDS, Tuberculosis and Malaria

GFBio The Global Fund for Biodiversity

GISAID Global Initiative on Sharing All Influenza Data

GISRS Global Influenza Surveillance and Response System

GLIS Global Information System

GUID Global Unique Identifier

IAF International Fund for Agricultural Development

IFC International Finance Corporation

IFFIm International Finance Facility for Immunisations

INSDC International Nucleotide Sequence Data Collaboration

IP intellectual property

IPBES Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem

Services

IRCC internationally-recognised certificate of compliance

ITPGRFA International Treaty on Plant Genetic Resources for Food and Agriculture

MAT mutually agreed terms

MLS multilateral system

NDA National Designated Authorities

NSD Nucleoside Sequence Data

PGRFA plant genetic resources for food and agriculture

PIC prior informed consent

PIP Framework Pandemic Influenza Preparedness Framework

RNA ribonucleic acid

SDGs Sustainable Development Goals

5

SMTA Standard material transfer agreement

SOI Sustainable Ocean Initiative

TK Traditional knowledge

TRIPS The Agreement on Trade-Related Aspects of Intellectual Property Rights

TRP Technical Review Panel

UK United Kingdom

UN United Nations

USA United States of America

WDCM World Data Centre for Microorganisms

WFCC World Federation for Culture Collections

WHO World Health Organization

WTO World Trade Organization

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Introduction

In 2016, the Conference of the Parties to the Convention on Biological Diversity (‘CBD’)1

recognised for the first time the relevance of, and potential issues surrounding, digital sequence

information on genetic resources (‘DSI’) for the achievement of the CBD’s three objectives:2

namely, the conservation of biological diversity, the sustainable use of its components and,

notably, the fair and equitable sharing of the benefits arising out of the utilization of genetic

resources.3 In light of the need for a coordinated and non-duplicative approach, the issue was

simultaneously raised by the Conference of the Parties serving as the Meetings of the Parties

(‘COP-MOP’) to the Nagoya Protocol on Access and Benefit-Sharing (‘the Nagoya

Protocol’).4 An Ad Hoc Technical Expert Group (AHTEG) was established and multiple

studies have been undertaken or are currently being conducted to shed light on the highly

technical and complex issue of how DSI relates to the scope and workings of the international

regime on access and benefit-sharing (‘ABS).5 DSI has been debated during the 2018 COP and

COP-MOP,6 and it is expected that DSI will remain a critical topic at the CBD COP15 as well

as in other international fora. Specifically, DSI is also being discussed under the Pandemic

Influenza Preparedness Framework (PIP Framework) of the World Health Organisation

(WHO)7, the International Treaty on Plant Genetic Resources for Food and Agriculture

(ITPGRFA)8 as well as current UN negotiations for a legally binding instrument on marine

biodiversity of areas beyond national jurisdiction (BBNJ).9

Difficulties in achieving progress on DSI under international regimes on biodiversity and

access and benefit-sharing, however, do not only stem from the technical complexity of the

subject, but also from the increasingly politicized nature of the debate and the resulting

polarised positions among CBD Parties. The current negotiating impasse is expected to have

an impact on the negotiations for a post-2020 Global Biodiversity Framework and may start to

1 Convention on Biological Diversity (adopted 5 June 1992, entered into force 29 December 1993) 1760 UNTS

79 (‘CBD’). 2 CBD COP, 'Digital Sequence Information on Genetic Resources' (2016) CBD/COP/DEC/XIII/16, Preamble 1. 3 Article 1 CBD. 4 Conference of the Parties to the CBD Serving as the Meetings of the Parties to the Nagoya Protocol ('COP-

MOP'), 'Digital Sequence Information on Genetic Resources ' (2016) CBD/NP/MOP/DEC/2/14. 5 See, for example, Convention on Biological Diversity (by S Laird and R Wynberg), 'A Fact Finding and Scoping

Study on Digital Sequence Information on Genetic Resources in the Context of the Convention on Biological

Diversity and Nagoya Protocol' (2018) CBD/DSI/AHTEG/2018/1/3 (‘Laird and Wynberg 2018’) and ‘2019-2020

Inter-Sessional Period. Studies on Digital Sequence Information on Genetic Resources’

https://www.cbd.int/abs/dsi-gr/2019-2020/studies.shtml, accessed December 2019. 6 CBD COP, 'Digital Sequence Information on Genetic Resources' (2018) CBD/COP/DEC/14/20 and COP-MOP

to the Nagoya Protocol, 'Digital Sequence Information on Genetic Resources' (2018) CBD/NP/MOP/DEC/3/12.

Please note that CBD COP15 has been postponed due to the continuing impacts of COVID-19;

https://www.cbd.int/doc/notifications/2020/ntf-2020-032-sbstta-sbi-en.pdf. 7 World Health Organisation, 'Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses

and Access to Vaccines and Other Benefits' (2011) A64/VR/10 (‘PIP Framework); see specifically PIP Advisory

Group's work on handling Genetic Sequence Data under the PIP Framework, available at

https://www.who.int/influenza/pip/advisory_group/gsd/en/?, accessed December 2019.

8 Summary of the Eighth Session of the Governing Body of the International Treaty on Plant Genetic Resources

for Food and Agriculture: 11-16 November 2019, Rome, Italy, Earth Negotiations Bulletin (09) 740. 9 3rd Session of the Intergovernmental Conference (IGC) on the Conservation and Sustainable Use of Marine

Biodiversity of Areas Beyond National Jurisdiction: 19-30 August 2019, UN Headquarters, New York, IISD

Reporting Services, available at https://enb.iisd.org/oceans/bbnj/igc3/, accessed December 2019.

7

undermine other international cooperation efforts on biodiversity more broadly, both under the

CBD and in other fora. This study examines if and how a sound international law solution can

be found to bridge and balance developed and developing countries’ demands for equity as

well as the need to support scientific research and scientific cooperation in the context of the

holistic realization of the three CBD objectives. This study will also seek to discern what non-

legal solutions might exist to the DSI issue. This study therefore assesses different legal and

non-legal options and identifies creative solutions to the issue of DSI, on the basis of three

starting points that are both principled and pragmatic:

Finding a legal solution that responds to the different needs of CBD Parties and

stakeholders around DSI can contribute to the broader effectiveness of the international

biodiversity regime;

Fostering learning across different regimes can also contribute to the effectiveness of

the international biodiversity regime: even if other international regimes are not

applicable, they can provide tested solutions and lessons learnt that can be adapted to

the context of the CBD; and

Moving beyond the false dichotomy of monetary and non-monetary benefits that often

characterises debates on ABS and DSI to ensure a functional approach and indeed, a

more expansive view of what constitutes benefits.

The results of this study aim to assist the European Commission in discussions with Member

States on possible ways forward.

a) Methodology and scope

This study will analyse and assess seven different options for addressing the issue of DSI: 1)

DSI is not covered by the CBD or the Nagoya Protocol; 2) DSI is covered by the CBD and the

Nagoya Protocol and no additional measures need be taken; 3) existing CBD/Nagoya Protocol

provisions are complemented by the implementation of a new track-and-trace system; 4) a

copyright-inspired sui generis system is put in place; 5) a multilateral DSI fund is put in place;

6) a broader, principled approach to benefit-sharing is taken, or; 7) a hybrid approach is taken.

Options 1 to 5 were partially pre-identified by the European Commission under the terms of

reference. Options 6 to 7 were identified on the basis of subsequent research. The analysis of

various options is based on a desk-based review of academic and grey literature pertaining to

DSI across different disciplines (such as law, natural sciences and political sciences).

The analyses take into account the wider possible effects of each option upon other policy areas

as well as whether any changes would lead to substantive sharing of benefits over time. In

terms of the scope of this study, while as noted above DSI is also a topic of debate under other

treaties, e.g. the International Treaty on Plant Genetic Resources for Food and Agriculture

(ITPGRFA) and the Pandemic Influenza Preparedness Framework (PIP Framework), these

areas are only considered for their mutual-learning value. The impacts of the different options

to address DSI on these international instruments are not the subject of this study. In the

conclusions this study will, however, consider the potential utility of the recommended options

to address DSI for the current UN negotiations on a legally binding instrument on marine

biodiversity of areas beyond national jurisdiction (BBNJ). It is finally to be noted that this study

8

will not address the ongoing question of how to effectively regulate the biosecurity concerns

surrounding synthetic biology.10

The research builds upon earlier work by Professor Elisa Morgera on fair and equitable benefit-

sharing conducted within the five-year BENELEX project (2013-2019).11 The study also

integrates insights on bio-prospecting and international scientific cooperation arising from the

development and implementation of the One Ocean Hub: an inter-disciplinary collaboration on

integrated ocean research and governance between UK and Global South research

institutions.12 In addition to desk-based research, the analyses have been informed by

confidential discussions with leading experts on DSI, notably with regard to the international

legal and political landscape relevant to DSI, including intellectual property law (Dr Shakeel

Bhatti in his personal/academic capacity), and the views of the scientific community on DSI

(Dr Rachel Wynberg, University of Cape Town, and Sarah Laird). These three experts have

indicated that this study has come to novel and helpful conclusions that could help bridge the

current divide in international negotiations and lead to a more constructive engagement with

different various stakeholders involved in bio-based innovation. We are extremely grateful for

the insights and assistance provided by these experts in helping to develop our thinking in

relation to this study.

b) Core assumptions and summary of findings

Our core assumption within this study is that in line with the international law principles of

good faith and effectiveness, DSI is within the scope of the CBD and the Nagoya Protocol but

cannot be adequately addressed through a bilateral approach, which is largely considered to

characterize ABS under the CBD and Nagoya Protocol. This approach has, in effect, led to a

series of legal and practical difficulties in implementation (that make addressing DSI quite

complicated under the CBD). It has also focused attention on a transactional approach/ logic

of exchange in the context of negotiating mutually agreed terms (MATs) that has been to the

detriment of the identification of opportunities for increased cooperation for the realization of

all the objectives of the CBD and their global benefits for human well-being as well as the

realization of the Sustainable Development Goals.

The problem underlying the bilateral approach inherent in the Nagoya Protocol in the DSI

context is the conceptualisation of DSI as ‘natural information.’ The fact that genetic resources,

10 For discussion, see, for example, A Rai and J Boyle, 'Synthetic Biology: Caught between Property Rights, the

Public Domain and the Commons' (2007) 5(3) PLoS Biology 0389; M Redford, ‘Genetic frontiers for

conservation : an assessment of synthetic biology and biodiversity conservation : technical assessment’, (IUCN,

2019) available at https://portals.iucn.org/library/node/48408, accessed December 2019; Secretariat of the

Convention on Biological Diversity (2019 Synthetic Biology, Montreal Technical Series No. 82; P Oldham, S

Hall and G Burton, ‘Synthetic Biology: Mapping the Scientific Landscape’ (2012) 7(4) PLoS ONE 1. 11 For more information, visit ‘The Benelex Project. Benefit-Sharing for an Equitable Transition to the Green

Economy’ at https://www.strath.ac.uk/research/strathclydecentreenvironmentallawgovernance/benelex/,

accessed October 2019. 12 For more information, visit ‘the One Ocean Hub’

https://www.strath.ac.uk/research/strathclydecentreenvironmentallawgovernance/oneoceanhub/, accessed

December 2019.

9

understood as natural information,13 are oftentimes not unique to a particular country,

alongside the range of publicly accessible databases (see discussion option 3 below) and ex situ

specimens, means that bilateral ABS arrangements, at least in respect of DSI, may become

increasingly difficult to operationalise.14 Conserved sequences, which “are similar or identical

sequences in DNA, RNA and proteins or polysaccharides occurring across species, or within

different molecules produced by the same organism”15 are also extremely common.16 This has

also led some commentators to argue that “the notions of sovereignty and countries of origin

… require reconsideration.”17

In addition, DSI poses significant challenges to the bilateral approach to ABS because of the

valuation of monetary benefits in respect of the contribution of DSI to commercial products,

and the resulting nature and extent of such monetary benefits. It has been underscored that “the

value of an individual sequence from a species may be very difficult to quantify”,18 because its

value lies in its potential to be screened with other sequences to find connections between traits

and functions.19 Similarly, one author remarked: “The modalities of genomic data (DSI) use

make traceability irrelevant: the value lies in the amounts of data analysed, rarely in a single

accession.”20 The long “cognitive and material distance” between a resource and a final product

is a challenge for valuation,21 if only a very small percentage of a particular sequence is used

or when the product of biotechnology has seen many transformations.22 Questions have

therefore arisen as to when benefit-sharing obligations cease to exist,23 and where such

obligations arise along a complex chain of providers and users. Further, and as set out above,

conserved or homologous sequences, as well as the spread of particular genes across

jurisdictions, present difficulties for valuation of monetary benefits from DSI.24

As set out above, genetic resources are often shared by countries with the spectre of

‘jurisdiction shopping’ therefore arising, resulting in oftentimes very low monetary benefits.25

This raises important issues of equity and has led to the question being asked as to whether the

current bilateral ABS approach embodied by the Nagoya Protocol does in fact support fairness

13 J H Vogel et al, 'Bounded Openness as the Modality for the Global Multilateral Benefit-Sharing Mechanism of

the Nagoya Protocol' in Charles R. McManis and Burton Ong (eds), Routledge Handbook of Biodiversity and the

Law (Routledge, 2017) 11. See also Laird and Wynberg 2018 (supra, n 5), 50 to 51. 14 Ibid. 15 Laird and Wynberg 2018 (supra, n 5), 50. 16 Ibid, 50 to 51. 17 M Ruiz Muller, 'Thinking Outside the Box Innovative Options for an Operational Regime on Access and Benefit

Sharing' (2010) ICTSD Issue Paper No. 1, 11 18 E W Welch et al, Potential Implications of New Synthetic Biology and Genomic Research Trajectories on the

International Treaty for Plant Genetic Resources for Food and Agriculture (Secretariat of the International Treaty

on PGRFA, 2017), 37. 19 Ibid. 20 S Aubry, ‘The Future of Digital Sequence Information for Plant Genetic Resources for Food and Agriculture’

(2019) 10 Front Plant Sci 1, 4. 21 Dutfield in D Scott and D Berry, Genetic Resources in the Age of the Nagoya Protocol and Gene/Genome

Synthesis (University of Edinburgh, 2016), 23. 22 Laird and Wynberg 2018 (supra, n 5), 51. 23 L N Slobodian et al, The Traceability of MGRs and Genomic Tech/Synthetic Biology (PharmaSea Milestones,

2017). 24 Laird and Wynberg 2018 (supra, n 5), 51. 25 Ruiz Muller 2010 (supra, n 17), 11. See also M Ruiz Muller, ‘Access to Genetic Resources and Benefit Sharing

25 Years on’ (2018) ICTSD Issue Paper No. 44, 11.

10

and equity in benefit sharing and support overall conservation and sustainable use.26 To the

extent that better tracking of DSI is possible to provide for monetary benefit-sharing - and this

in itself is perhaps questionable (see options 3 below and 4 below) – the ability to track would

not address issues of fairness and moreover equity associated with the current bilateral ABS

system under the Nagoya Protocol.27

Accordingly, while in our view DSI is within the scope of the Nagoya Protocol and CBD

(option 1 below), we contend that the prevailing bilateral approach under the Protocol is neither

desirable nor practicable to deal with the issue of DSI. Accordingly, we reject the notion that

benefits from the use of DSI need only be dealt with by via MAT and no additional measures

need be taken to deal with the peculiarities of DSI, because this approach appears out of sync

with current scientific practices (option 2 below). We further explore whether additional

measures, particularly via the introduction of new mechanisms to track and trace DSI would

facilitate the operation of the bilateral ABS system under the Nagoya Protocol but as noted

above, do not find this option to be particularly feasible. This is due to difficulties arising under

the bilateral system regarding the monitoring of use and the intractability of determining the

value and nature of benefit-sharing obligations (option 3 below). We further explore whether a

sui generis system of copyright-like protection (option 4 below) for DSI may offer a solution

but find that the complexity and likely cost of such a system may very well outweigh its

potential benefits.

Based upon our analysis in options 1 to 4, we argue that the need for legal certainty, and the

difficulties of achieving such certainty on a bilateral basis, weighs in favour of a multilateral

solution. We therefore explore in option 5 potential options for a multilateral approach to

monetary benefit-sharing in respect of DSI. We discuss a menu of potential options for the

accrual of monetary benefits under such a fund as well as potential sites for its governance. In

particular, we identify three potential sites for the operation of such a fund: (1) a multilateral

approach based on Article 10 of the Nagoya Protocol, (2) a global fund for biodiversity under

the CBD (and therefore centred under the UN system) and, (3) a global fund for biodiversity

outside of the existing ABS system. Our favoured approach is for a fund under the CBD, since

it is its Treaty objectives which would underpin such a fund. We note, however, that a fund in

itself would not necessarily adequately address the equity issues and foster the needed

cooperation to harness DSI for the realization of the three objectives of the CBD. We thus

explore in option 6 below whether more principled approaches are needed to ensure that

available resources are targeted to ensure fairness and equity. In essence, while a multilateral

fund for the sharing of benefits is very much needed to make a system to address DSI viable,

this should be functional to supporting a multilateral platform for dialogue, learning, oversight

and priority setting, on the best ways to achieve fairness and equity in benefit-sharing from

DSI. Such an approach would ensure that the system would respond to the needs of expected

beneficiaries and allow the international community to understand and respond to the different

communities involved, including by addressing the needs of scientific researchers.

26 See generally Ruiz Muller 2018, ibid, 27 See generally ibid, but see particularly 11.

11

In option 7 (a hybrid approach), we combine the multilateral platform for dialogue, learning,

oversight and priority-setting for DSI envisaged in option 6 below with the multilateral fund

for distribution of benefits set out in option 5 below. We propose various mechanisms to

support the financial viability of such a fund, including formulation of a digital domaine public

payant which would be based on a copyright-like approach and see DSI regulated as a semi-

commons under which a fee could either be paid for access to or use of DSI, to support the

objectives of the CBD. Databases could form a natural point of entry for the operation of the

digital domaine public payant. More significantly, the multilateral platform for dialogue,

learning, oversight and priority setting would seek to work collaboratively with all relevant

stakeholders – both in the Global North and the Global South – to create opportunities for

consensus building on DSI. It could also provide a clear response to the latest alarming data on

the implications of the global biodiversity crisis for the realization of the SDGs and the

protection of fundamental human rights. We return in this section to the opportunities to take

a multilateral approach under the CBD and the Nagoya Protocol, underscoring the advantages

of placing the hybrid approach under the Convention. The hybrid approach outlined in

option 7 is very much our preferred approach to resolving the DSI issue.

12

Option 1: DSI is not covered by the CBD or the Nagoya Protocol

In this option, we explore the contention that DSI does not come within the scope of the

CBD or the Nagoya Protocol. After setting out the background to such arguments, we contend

that the application of the general principles of international law of effectiveness and good

faith, combined with a desire for legal certainty, indicates that this is not a recommended

option. We contend that considering DSI within the scope of the CBD and the Nagoya Protocol

is likely to produce positive externalities for law and policy and allow for a more structured

approach to the issue across different sectors and regimes.

a) The conceptual underpinnings of the debate over whether DSI comes within the

scope of the CBD and Nagoya Protocol

The topic of DSI poses conceptual questions for the international ABS regime, with the status

of DSI under the CBD and the Nagoya Protocol having been discussed extensively but without

Parties being able to find agreement. Firstly, the terminology ‘DSI’, which was introduced by

the CBD,28 is not uncontentious as the scientific community and other international processes

use related terms, such as ‘resources in silico’ and ‘(genetic) sequence information/data’ which

have been held to more accurately and comprehensively represent the subject at hand.29

Secondly, Parties’ views and those from organisations who have provided submissions to

inform the process diverge with regard to the subject-matter scope of the CBD and the Nagoya

Protocol in relation to DSI, notably in light of the interpretation of the terms ‘utilization of

genetic resources’.30 Arguments against inclusion focus on the dematerialised state of DSI and

presume that the definitions under the CBD only apply to physical resources.31 Contrarily,

arguments in favour of inclusion put forward that the terms under the CBD should include both

tangible and intangible components, “i.e. the physical material as well as the actual or potential

value it contains in the form of information”.32 The invitation for submission of views for the

2019-2020 called for further terminological clarification,33 although some Parties have

remarked that such further technical discussions are unlikely to break the current impasse.34 In

the meantime, the CBD AHTEG group met in March 2020 to consider a number of

28 CBD Decision Xiii/16. 29 For a thorough analysis of the challenges surrounding the ‘DSI’ terminology, see Laird and Wynberg 2018

(supra, n 5), Chapter 2. On terminology and the scope, see also M Bagley and A K Rai, The Nagoya Protocol and

Synthetic Biology Research: A Look at the Potential Impacts (Wilson Centre, 2013), 20-21. 30 See, for example, Art. 1 CBD and Art. 1 Nagoya Protocol. See also, Preamble 17 and Article 3(4) an (5)

Regulation (Eu) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on Compliance

Measures for Users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing

of Benefits Arising from Their Utilization in the Union [2014] OJ L 150/59. 31 See notably Ad Hoc Technical Expert Group ('AHTEG') on Digital Sequence Information on Genetic

Resources, 'Synthesis of Views and Information on the Potential Implications of the Use of Digital Sequence

Information on Genetic Resources for the Three Objectives of the Convention and the Objective of the Nagoya

Protocol' (2018) CBD/SBSTTA/22/INF/2, 36. 32 Ibid, 35. 33 ‘Digital Sequence Information on Genetic Resources: Submission of Views and Information and Call for

Expression of Interest to Undertake Studies’ (Secretariat to the CBD, 2019)

https://www.cbd.int/doc/notifications/2019/ntf-2019-012-abs-en.pdf, accessed October 2019 34 See, for example, ‘Submission by the African Group of Negotiators on Biodiversity-Ad Hoc Group on Digital

Sequence Information’ (Secretariat to the CBD, 2019).

13

commissioned peer reviewed studies35, including on the concept and scope of DSI36, and agreed

that while RNA, DNA, proteins, epigenetic modifications, metabolites and other

macromolecules could be considered DSI, other ‘associated information’ such as traditional

knowledge would not be considered DSI.37 It remains to be seen how this will be responded to

by the Parties at CBD COP15.

b) A legal and policy basis analysis of the inclusion of DSI with the CBD and Nagoya

Protocol

While views may diverge on the most persuasive legal interpretation of the scope of the ABS

regime, a solution capable of fostering increased cooperation and multilateral learning should

be favoured under general principles of international law, notably effectiveness and good

faith.38 These principles support interpretations that contribute to ensure full effect of a treaty,

in light of its object and purpose, rather than depriving provisions of impact on the ground.39

In this regard, it seems to be self-evident that the benefits associated with a genetic resource is

often linked to the information held within a genetic resource in addition to the physical traits

of the specific specimen (see core assumptions above). The exclusion of DSI from the scope

of the CBD and the Nagoya Protocol is therefore considered to be contrary to the principles of

effectiveness and good faith.

A question of relevance to DSI and ABS is, moreover, to what degree data and information can

be used to generate benefits without access to the physical resource, which would mean that

requirements that follow from international law could be avoided altogether when DSI is

excluded from its scope. Whereas current scientific practices mostly use sequences to

complement rather than substitute work on physical organisms,40 rapid technological

developments could allow for further detachment in the future.41 Advances in gene synthesis,

for example, are likely to reduce the need for reliance upon physical samples. Any policy

choice should anticipate this potential.

Exclusion of DSI from the scope of the CBD and the Nagoya Protocol is also likely to

“maintain an uncertain position or the perpetuation of disagreements”,42 and enables the

35 See generally https://www.cbd.int/dsi-gr/2019-2020/studies/ 36 W Houssen and others, Digital Sequence Information on Genetic Resources: Concept, Scope and Current Use

(2020) Convention in Biological Diversity. 37 Secretariat to the Convention on Biological Diversity, ‘Report of the Ad Hoc Technical Expert Group on Digital

Sequence Information on Genetic Resources’ (20 March 2020) CBD/DSI/AHTEG/2020/1/7 38 Secretariat to the Convention on Biological Diversity (prepared by E Morgera, S Switzer and E Tsioumani),

'Study into the Criteria to Identify a Specialised Access and Benefit-Sharing Instrument, and a Possible Process

for Its Recognition' (2018) UN Doc CBD/SBI/2/INF/17, 14. 39 M Fitzmaurice, ‘The Law of Treaties’ in Malcolm Nathan Shaw (ed), International Law (Oxford University

Press 2008), 832-838. 40 Laird and Wynberg 2018, (supra, n 5), 32. 41 C Lawson and M Rourke, ‘Open Access DNA, Rna and Amino Acid Sequences: The Consequences and

Solutions for the International Regulation of Access and Benefit Sharing’ (2016) 24 Journal of Law and Medicine

96, 116 refers to one example under the PIP Framework where a vaccine was produced without access to a physical

sample. 42 E Morgera, ‘Fair and Equitable Benefit-Sharing in a New International Instrument on Marine Biodiversity: A

Principled Approach Towards Partnership Building?’ (2018) 5 Maritime Safety and Security Law Journal 48, p

14

continuation of an international legal vacuum on DSI. Contrarily, the principles of

effectiveness and good faith privilege, “better protection or implementation of universal values,

and in addition [ensure] international institutions are involved to monitor or steer the

process.”43 Whereas some members of the scientific community may primarily anticipate

positive impacts from exclusion due to the likelihood of ongoing unrestricted access to DSI,44

it may be that provider-countries will impose stricter restrictions on the generation and

publication of DSI in legislation on access.45 That said, it is to be noted that bulk of Nucleoside

Sequence Data (NSD) deposits to the International Nucleotide Sequence Data Collaboration

(INSDC) are from 4 countries – USA, China, Canada, and Japan, which together account for

more than 50% of country-tagged NSD.46

Exclusion from the scope of the CBD and the Nagoya Protocol can overall be considered a lost

opportunity to maximise the contribution of DSI to the CBD obligations on scientific research

and cooperation that contribute to realizing the CBD’s objectives of conservation and

sustainable use, although these are to be balanced against other public goods. Moreover, it may

lead to inequitable outcomes for biodiversity-rich countries by circumventing the third

objective of the CBD on fair and equitable benefit-sharing, as a consequence of changing

scientific practices. Exclusion of DSI from the scope of the CBD and the Protocol is

therefore not a recommended option.

68 and A Orakhelasvili, The Interpretation of Acts and Rules in Public International Law (Oxford University

Press, 2008), 395. 43 S Zappalà, ‘Can Legality Trump Effectiveness in Today’s International Law?’ in Antonio Cassesse (ed),

Realizing Utopia (Oxford University Press 2012), 105. 44 See, for example, ‘Submission by the League of European Research Universities (Leru). Digital Sequence

Information = Nucleotide Sequence Data! But More Clarity Is Needed on Its Scope. ’ (Secretariat to the CBD,

2019) https://www.cbd.int/abs/DSI-views/2019/LERU-DSI.pdf, accessed October 2019. 45 S J Hiemstra et al, Digital Sequence Information (DSI). Options and Impact of Regulating Access and Benefit

Sharing - Stakeholder Perspectives (University of Wageningen, 2019), 13. See also, M A Bagley, Digital DNA:

The Nagoya Protocol, Intellectual Property Treaties, and Synthetic Biology (Wilson Centre, 2015), 7-8. 46 F Rohden et al, Combined Study on Dsi in Public and Private Databases and Dsi Traceability (Convention on

Biological Diversity, 2019.

15

Option 2: DSI is covered by the CBD and the Nagoya Protocol: benefits from use of DSI

are to be included in MAT and no additional measures are taken

The question as to whether DSI is included in the scope of the CBD and the Nagoya Protocol

is separate to, and logically precedes, the question of how the provisions of either treaty can

apply to DSI. Agreement on the inclusion of DSI within the scope of the CBD and the Nagoya

Protocol would therefore have the advantage of allowing international discussions to move

forward, onto the question: to what extent can these two treaties apply to DSI? In this option,

we explore the contention that no additional measures need be taken to deal with the specific

situation of DSI, assessing whether current arrangements under the Nagoya Protocol can bring

about benefit-sharing from the use of DSI.

The Nagoya Protocol stipulates that access to genetic resources for their utilisation is subject

to prior informed consent from the country of origin,47 and that benefits arising from the

utilisation of genetic resources as well as subsequent applications and commercialisation shall

be shared in a fair and equitable way with the country of origin, upon mutually agreed terms

(‘MAT’).48 These provisions of the Nagoya Protocol thus rely on the idea that a single resource

generates benefits for a user that should be shared with the provider MATs. The draft fact-

finding study conducted for the CBD on domestic measures that address the use of DSI show

that some countries include conditions on the use of DSI as part of prior informed consent

(PIC) and MAT.49 Malawi, for example, includes in its MAT that publication of DSI must be

accompanied by a statement that the government of Malawi, “has commercial rights or other

further use rights in products or processes developed based on the research results of this DSI

[and that] Malawi requires what may be called a certificate of acknowledgement of source and

rights, to be included in digital publications”.50

It is, however, questionable whether this obligation suits the current open-access infrastructure

and, for example, the submission formats used by INSDC. More importantly, the bilateral

nature of MAT fails to take into consideration that DSI is not used as the sole source for bio-

innovation, but it is rather screened with other sequences to find connections between traits and

functions. In other words, the premises upon which MATs are based are out of sync with

current research practices, resulting in difficulties in the valuation of monetary benefits in

respect of the contribution of DSI to commercial products, and in determining if and when

benefit-sharing obligations cease to exist. Finally, transparency issues in the biotech sector may

result in difficulties in obtaining information regarding both profits and monetary benefits

relating to the use of DSI. In conclusion, the inclusion in MATS of DSI is likely to be

plagued by a mismatch with current scientific practices, and the intractability of

determining the value and nature of benefit-sharing obligations. Therefore, this is not a

recommended option.

47 Article 7 Nagoya Protocol. 48 Article 5(1) Nagoya Protocol. 49 E K Margo Bagley, Manuel Ruiz Muller, Frederic Perron-Welch, Siva Thambisetty, Fact-Finding Study on

How Domestic Measures Address Benefit-Sharing Arising from Commercial and Non-Commercial Use of Digital

Sequence Information on Genetic Resources and Address the Use of Digital Sequence Information on Genetic

Resources for Research and Development (Convention on Biological Diversity, 2019). 50 Ibid, 23. See also Submission on DSI by the African Group to the CBD 2019, 4.

16

Option 3: The current system is complemented by a new track-and-trace system

In this option, we assume DSI is considered to fall within the scope of the CBD and the

Protocol, and additional measures are necessary to ensure benefit-sharing from the use of DSI.

Specifically, we explore the contention that the current bilateral approach to ABS could be

made operational with regard to DSI through a new track-and-trace system.

In this regard, we explore a number of potential options such as the use of a new monitoring

system for the retracing of the source of DSI or the application of blockchain technology to

DSI. Due to difficulties in the implementation and operation of these systems, we do not see

blockchain as a recommended option. Where the focus is put on track-and-trace only, the

improvement of existing structures is needed. However, we contend that improved tracking

does not resolve significant issues related to valuation in the bilateral ABS system. Indeed,

within the proposed solution of a multilateral platform (Option 6 below), improving options

for tracking should not be the primary focus, but such improvements – where they target

existing infrastructures – could contribute to enhancing the interoperability of systems.

a) Background

It addition to the difficulty of valuing netary benefits discussed under option 2 above, there are

other factors that complicate the application of the current ABS regime to DSI, relating to the

(in)ability to track information and to monitor use . With regard to NSD, as a specific form of

DSI, there is already something of a tracking system in place under the INSDC database

structure, which could be further built upon, but even improved implementation is still likely

to pose challenges for monitoring and the valuation of monetary benefits. The draft study on

traceability conducted for the CBD emphasised that moving beyond existing infrastructures for

NSD is likely to be costly, will lead to separation and fragmentation of processes, with negative

impacts on research, and may come with its own practical and technical challenges.51 Keeping

this in mind, this section will consider two options for a new track-and/or-trace system in light

of the potential to overcome persistent issues of monitoring: a system to trace back the origin

upon use and a blockchain-based system.

b) Retracing of information

Track-and-trace is not a term with a single unified definition; instead, it may refer both to

systems that trace back to the original source upon (commercial) use, or to the continuous

tracking processes of information and use along the value chain. Examples of the former

include tools developed under the World Federation for Culture Collections (WFCC) and the

World Data Centre for Microorganisms (WDCM), to search different databases to identify

uses.52 Yet, it is recognised that the success of such a monitoring system for (commercial) end-

uses only is still ultimately dependent on a form of a downstream support system that allows

51 Rohden et al 2019 (supra, n 46), 50 and 52. 52 PIP Framework Advisory Group on Monitoring Options 2015, 15; see also P Desmeth, ‘The Nagoya Protocol

Applied to Microbial Genetic Resources’ in Ipek KurtboK (ed), Microbial Resources: From Functional Existence

in Nature to Applications (Academic Press 2017), 214-215 on the TRUST system.

17

for consistent identification of the source. On the other hand, a ‘regularising procedure’ in cases

where such provenance cannot be established, “must remain exceptional”.53 In case of the

WFCC and the WDCM, such a support system consists of the Global Catalogue of

Microorganisms,54 and the Global Unique Identifiers (GUIDs).55 It must, however, be noted

that monitoring of commercial use at the end of a value chain based on retracing of the source

is in these instances only applied to specific sub-categories of genetic resources and that it is

highly uncertain that the approach could be extended to include uses of all genetic resources

and DSI.56 Indeed, although the recent CBD study on traceability found that 16% of studied

DSI submissions to the INDSC had a country tag and for 44% of samples the country of origin

could be obtained from the publication, this still leaves a large percentage of submissions for

which the country of origin is missing.57

With regard to genetic resources, for example, the EU puts a ‘due diligence’ obligation on

users, obliging them to: “seek, keep and transfer”58 important documents such as the

internationally-recognised certificate of compliance (IRCC) or equivalent information that

includes the date and place of access, a description of the resource, its source, the presence or

absence of rights and obligations relating to benefit-sharing, access permits and MAT.59 Even

with regard to physical resources, this chain is often non-linear, with resources, for example,

being shared among ex situ collections before being passed to other users, posing difficulties

for tracking and involving administrative burdens that some (notably non-commercial) users

may find hard to comply with.60 The particular nature of DSI means that some issues related to

the tracking of information, notably with regard to identifying provenance through the research

process, may be amplified.

As identified by the recent combined study conducted for the CBD on ‘DSI in public and

private databases and DSI traceability’,61 there are, however, some existing infrastructures that

could contribute to resolving issues of tracking with regard to certain types of DSI, notably

Nucleotide Sequence Data (NSD), without the need for implementation of a new track-and-

trace system. NSD “are the direct outcome of nucleotide (DNA or RNA) sequencing of a

53 Mosaicc - Micro-Organisms Sustainable Use and Access Regulation International Code of Conduct (Belgian

Co-ordinated Colletions of Micro-Organisms, 2011), p7; also Submission of the World Federation for Culture

Collection (Wfcc), World Data Centre for Microorganisms (Wdcm) & Transparent User-Friendly System of

Transfer Programme (Trust) for Notification Scbd/Abs/Vn/Kg/Jh/86849 (Secretariat to the Convention on

Biological Diversity, 2018), 3. 54 ‘Global Catalogue of Microorganisms’ http://gcm.wfcc.info/, accessed November 2019. 55 Desmeth 2017 (supra, n 52), 216. 56 Note in this regard also P Oldham and S Hall, Intellectual Property, Informatics and Plant Genetic Resources

(FAO, 2012), 203-208, which suggests in the context of the ITGPRFA that although patents can still often be

traced back to species listed in Annex I of the treaty, that this is likely due to its limited scope and the nature of

agricultural biotechnology. 57 Rohden et al 2019 (supra, n 46), 42-43, it is noted, however, that this covers the total amount of INSDC entries

but as newly submitted sequences have a much higher percentage of country reporting, so the coverage will

increase. 58 Article 4(3)(b) Regulation (EU) No 511/2014. 59 Article 4(3)(b)(i-vi) Regulation (EU) No 511/2014. 60 E Morgera and M Geelhoed, 'Utilisation' in the Nagoya Protocol and the Eu Abs Regulation for the Upstream

Actors (University of Edinburgh, for the European Commission, 2016), 29. 61 Rohden et al 2019 (supra, n 46).

18

genetic resource”,62 and also include “information on the sequence assembly, its annotation

and genetic mapping.”63 In particular, where NSD, as a precondition of publication, is

submitted to the International Nucleotide Sequence Data Collaboration (INSDC), 64 it is given

an individual Accession Number (AN), which is the “cornerstone of NSD traceability”.65 Since

1998, a metadata field to provide information on the country of origin has been provided in the

INSDC database submission form and it has been mandatory to submit this information since

2011.66 Also, it could be possible within the INSDC to add a field for reference to the unique

identifier of the IRCC.67 Lastly, it could be possible to be given an AN for metadata associated

with NSDs, which allows for submission of one form for a project that may cover hundreds or

thousands of sequences that are linked to a single collection.68

The INSDC is central to the wider network of databases for NSD.69 Nonetheless, its current

potential is limited by the fact that only 16% of analysed NSD did come with a country tag,

and none made reference to MAT.70 Moreover, it has been held that due to the volume of

transactions the system may be prone to human error,71 and can – due to its openness – be

misused by users in bad faith.72 Ensuring user compliance through monitoring and enforcement

is likely to be an issue whilst a single sequence can be split into parts, synthesised and modified

in a way that it can be made unrecognisable,73 and can be reused indefinitely.74 Once linkages

between DSI and its original source have been lost, retracing may be very difficult.75 A further

complicating factor is the fact that algorithms can be used to compare sequences to others that

exist in other databases, allowing users to identify similar sequences that do not have the same

restrictions on use and obligations on benefit-sharing.76 The resulting unintended consequences

could be that some sectors that are more closely linked to specific conditions in certain

countries will be more negatively impacted by the obligations that follow from the international

62 Ibid, 11. 63 Ibid, 11. 64 Journals and literature search engines also use Digital Object Identifiers (DOI) to link the respective publication

back to the submitted NSD. 65 Rohden et al 2019 (supra, n 46), 2. 66 Ibid, 27-28. 67 Ibid, 36. 68 Ibid, 33. 69 Ibid, 15. 70 Ibid, 39 and 3. It is noted that for 44% of studied NSD entries without a country tag this information could be

retrieved from the publication, and the omission was believed to be primarily caused by automated uploads of

large amounts of sequences with incomplete metadata; a process that could still be optimised (p 43). 71 Ibid, 38. See on the volume of transactions also E Karger, Study on the Use of Digital Sequence Information on

Genetic Resources in Germany (German Competent National Authority for the Nagoya Protocol, 2018), 28. 72 Rohden et al 2019 (supra, n 46), 45-46. 73 Laird and Wynberg 2018 (supra, n 5), 54. 74 Karger 2018 (supra, n 71), 29. 75 Lawson and Rourke 2016 (supra, n 31), 116. 76 Welch 2017 (supra, n 18), 14.

19

ABS regime,77 and that other sectors may choose to move away from those countries which

have put ABS rules in place, potentially to the detriment of conservation research.78

c) Blockchain

Where monitoring end-uses is unlikely to be a successful track-and-trace option for all DSI that

would fall within the scope of the CBD and the Nagoya Protocol, the focus has generally been

on continuous and consistent tracking of provenance along the value chain. Tracked metadata

can further include legal documentation (with PIC/MAT) or it can adopt a more hybrid

approach where such information can be retrieved through a separate but interlinked legal

database. One option that is frequently mentioned as a new tracking solution is blockchain

which is a type of distributed ledger technology. It is most well-known for its application to

Bitcoin, but its potential has been recognised much more broadly.79 It is considered to promote,

“the empowerment of citizens”80 more generally, or of specific users groups in particular, by

giving them the opportunity to control their own data, because the technology is autonomous

in the sense that it does not rely on a central authority or third party to be implemented.81 Put

simply, blockchain “is an open ledger of information that can be used to record and track

transactions, and which is exchanged and verified on a peer-to-peer network”.82 As the name

suggests, blockchain consists of a chain of blocks with information, which are

cryptographically time-stamped and linked to record any transaction. The information in the

chain is immutable, which means that it is very difficult to change the information in the blocks,

thereby providing protection against tampering. A block has a unique hash which identifies the

block and its content. Each block also contains the hash of the previous block, thus creating a

chain, which makes it suitable for tracking and tracing.

For the purpose of tracking in the context of DSI, blockchain could, in theory, allow for the

transfer of sequence data,83 and of accompanying information on provenance and terms of use,

throughout complex value chains. The approach of blockchain likewise aligns well with the

fluid, open access, and networked approach of DSI today. There are, however, other advantages

associated with the use of blockchain. Firstly, terms of use may not only be included as

metadata but can also be attached through so-called smart contracts. Smart contracts are

computer programs that can automatically perform some functions,”84 for example the

execution of simple, pre-specified terms and conditions, thereby boosting the speed and

77 This includes, for example, agriculture which often requires a focus on the region where a specific crop is

grown, see Laird and Wynberg 2018 (supra, n 5), 51. 78 See, for example, ‘Joint Submission on Digital Sequence Information on Genetic Resources – Concept and

Benefit-Sharing’ (Secretariat to the CBD, 2019) https://www.cbd.int/abs/DSI-views/2019/DNFS-VBIO-LVB-

DSI.pdf, accessed October 2019, 4. Also, example Scott and Berry (supra, n 21), 37. 79 See, for example, European Parliament, 'Resolution on Distributed Ledger Technologies and Blockchains:

Building Trust with Disintermediation' P8_TA(2018)0373. 80 Ibid, Preamble A. 81 Rohden et al 2019 (supra, n 46). 82 B Clark, ‘Blockchain and IP Law: A Match Made in Crypto Heaven?’ (WIPO Magazine 2018)

https://www.wipo.int/wipo_magazine/en/2018/01/article_0005.html, accessed November 2019. 83 This, however, is complicated by the fact that large sequences will use of massive storage space and

computational power, Rohden et al 2019 (supra, n 46), 48. 84 G Hileman and M Rauchs, ‘Global Blockchain Benchmark Study’ (Cambridge Centre for Alternative Finance,

2017) https://www.ey.com/Publication/vwLUAssets/ey-global-blockchain-benchmarking-study-2017/$FILE/ey-

global-blockchain-benchmarking-study-2017.pdf, accessed November 2019.

20

efficiency of transactions.85 These may function similarly to click-through-agreements which

require acceptance of the conditions of use before access to the sequence, with the additional

advantage of providing a record that the terms were accepted by the user.86 Moreover, simple

terms could be made easily executable through smart contracts thus solving potential issues of

enforcement. Smart contracts “trigger transactions automatically when certain pre-defined

conditions are met”.87 For example, access to DSI could, in theory, be conditioned upon

payment of a fee. More profoundly, it has been suggested that smart contracts and blockchain

could be used to establish and enforce intellectual property (IP) licenses and transmit payments

of licensing fees or royalties to IP owners.88 Furthermore, encryption for confidential IP data

could, for example, be used to provide protection for trade secrets and facilitate compliance

with the EU Trade Secrets Directive.89

There are, however, also disadvantages associated with the use of blockchain technology. From

a holistic environmental perspective, its current energy footprint should not be disregarded.

The technology relies on the computational power of each participant in the network (called

nodes) but it is estimated that bitcoin’s energy consumption alone, and notably a process called

‘proof-of-work’ which gives the blockchain ledger security against tampering, is comparable

to the annual energy consumption in Austria, “which costs 3.628 billion USD annually” and

exacerbates resource use and carbon emissions.90 In addition, it is also predicted to require

“high up-front investment for the setup of the system and permanent infrastructure costs for

the upkeep”.91 Accordingly, the benefits generated by such an expensive system are likely to

be outweighed quite significantly by its broader costs.

The same study also signals two other important risks of introducing the blockchain technology

for track-and-trace of DSI: the first relates to the fact that DSI can easily be distributed outside

of the chain and there is no clear incentive for other users to remain within the blockchain.92

While bitcoin taken outside the blockchain loses all value, which practically ensures that users

have all the interest to stay within the system, the same cannot be said for DSI.93 DSI outside

of the blockchain system is still equally valuable as DSI,94 so there is no incentive to remain

within block chain once DSI has been obtained. It is difficult to see how this lack of incentive

85 F Perron-Welch, ‘Blockchain Technology and Access and Benefit-Sharing’ (ABS Canada, 2018)

<http://www.abs-canada.org/food-for-thought/blockchain-technology-and-access-and-benefit-sharing/>,

accessed November 2019. 86 Ibid, 47. 87 A Kumar, ‘Smart Contracts on the Blockchain: A Deep Dive into Smart Contracts’ (Medium 2017)

https://medium.com/@abhibvp003/smart-contracts-on-the-blockchain-a-deep-dive-in-to-smart-contracts-

9616ad26428c, accessed November 2019. 88 C Frison et al, ‘Blockchain Technology for IP Management & Governance: Exploring Its Potential to Restore

Trust and Resilience in the Plant and Biomedical Sectors’ (Modern Intellectual Property Governance and

Openness in Europe: A Long and Winding Road?), 2018, Abstract. See also Clark 2018 (supra n 82). 89 Directive 2016/943 on the Protection of Undisclosed Know-How and Business Information (Trade Secrets)

against Their Unlawful Acquisition, Use and Disclosure [2016] OJ L OJ L 157/1; ‘How Can Blockchain and

Trade Secrets Support Each Other?’ (Mathias Avocats 2017) https://www.avocats-mathias.com/droit-des-

affaires/blockchain-trade-secrets, accessed November 2019. 90 Rohden et al 2019 (supra, n 46), 47. 91 Ibid, 50. 92 Ibid, 50. 93 Ibid, 50 94 Ibid.

21

for users to stay within the blockchain could be overcome. The second risk is that introduction

of a new system that is not necessarily compatible with existing infrastructures (notably

INSDC) may lead to (further) fragmentation of efforts, and increase user costs, with a knock-

on effect for innovation and scientific collaboration. Furthermore, many users of DSI are in the

Global South, and so this would need to be borne in mind when considering any proposals that

add to the cost of use. As has already been noted in the context of a monitoring and tracking

study conducted ten years ago, it is not the theoretical and technical feasibility of a system that

often determines its success, but such a system must also be socially tested to ensure that the

needs of users are met, in order to effectively promote widespread application.95

Lastly, it must be noted that legal complexities may also be associated with the use of

blockchain technology, related to potential issues of compliance with the EU’s General Data

Protection Regulation (GDPR) for a network that is publicly accessible,96 and challenges of

determining applicable law and jurisdiction as blockchain is detached from any centralised

authority.97

d) Moving beyond track-and-trace

It follows from the above that as a track-and-trace system, blockchain is unlikely to be the

preferred option. Indeed, as discussed above, opportunities have been identified to further

develop existing structures like tracking under the INDSC, by creating better linkages with the

original genetic resource and improve traceability of the country of origin, as well as create a

new metadata field to include information on the internationally-recognised certificate of

compliance (IRCC).98 In light of the cost effectiveness and high user acceptance of reliance on

existing, widely used structures, improvement of such structures is likely to be preferable.

Nonetheless, such an improved track-and-trace system still does not address the significant

problems of valuation of monetary benefits (option 2 above) of the current bilateral system that

relies on the negotiation of MATs. It is therefore not a recommended option.

Within the proposed hybrid approach we set out in options 6 below and 7 below, the practical

value of improved tracking-and-tracing for the operation of a multilateral platform is limited,

and will therefore not be the focus of the recommendations under this study. Nonetheless,

efforts to improve the general interoperability of systems related to DSI should be encouraged,

and as we explore in option 6 below, inspiration can be taken from the Global Information

System (GLIS) under the ITPGRFA.

95 G M Garrity et al, Studies on Monitoring and Tracking Genetic Resources (Secretariat to the Convention on

Biological Diversity, 2009). Similarly, also Desmeth 2017 (supra, n 52), 211: “The misperception of the situation

by the lawmakers and inappropriate expertise input during and around the negotiations led to inappropriate

solutions that are seen as not relevant and thus rejected because not credible by actors in the field.” 96 T Lyons et al, Blockchain and the GDPR (The European Union Blockchain Observatory and Forum, 2018); 97 Frison et al 2018 (supra, n 88); J Mckinlay et al, ‘Blockchain: Background, Challenges and Legal Issues’ (DLA

Piper Publications 2018) https://www.dlapiper.com/en/denmark/insights/publications/2017/06/blockchain-

background-challenges-legal-issues/, accessed November 2019. 98 Rohden et al 2019 (supra, n 46), 53.

22

It is, lastly, important to note that the recommendations in this study focus on DSI in public

databases, like the INDSC. Questions related to DSI from private databases, which is a niche,

although significant, area, would need to be studied in their own right.

23

Option 4: A sui generis system inspired by copyright

Following on from the above discussion, it is clear that the search for ways forward in respect

of DSI may need to include other domains of law. In this regard, intellectual property has

frequently been raised as having possible relevance to the protection of genetic resources as

well as traditional knowledge associated with genetic resources. The relevance of IP law can

be indirect, however: and we explore here whether IP law has already addressed similar issues

that are faced under the CBD and the Nagoya Protocol with reference to DSI and therefore

whether certain legal solutions and lessons learnt can be explored as a source of inspiration

under the CBD and Nagoya Protocol. In other words, we are not exploring the applicability of

IP law to DSI, which would raise questions about pre-empting negotiations under the World

Intellectual Property Organization. What we are exploring here is what international

biodiversity law can learn from IP law in dealing with comparable challenges, with a view to

devising an ad hoc approach under the CBD and/or the Nagoya Protocol. Such an approach

would not be grounded in IP law as such, but draw on useful approaches and tested solutions

that have been found in that domain. Notably, copyright law has evolved into a carefully

nuanced system that contains specific solutions potentially capable of responding to the

need of different users along a complex value chain that could be compared to that for

DSI. On that basis, we discuss how the tested approaches developed for copyright can be

adapted to the context of DSI with a view to 1) recognizing and rewarding the contribution of

States that conserve biodiversity on the basis of which DSI is generated; and 2) recognizing

more equitably the contributions of researchers in the Global South to the conservation of

biodiversity in their own countries and responding to their needs to collaborate with other

innovators along the DSI value chain.

Accordingly, in this section we explore the application of solutions inspired by copyright to

examine whether a sui generis system of protection could act as a possible way forward to

address the above-noted concerns surrounding DSI. In doing so, we explore a number of

possible options for such a sui generis system of protection. We conclude that a number of

practical issues might preclude the adoption of a sui generis regime based on copyright in and

of itself. But there is scope to infuse elements of a sui generis system based on copyright as

part of a broader hybrid approach to DSI, explored more fully in option 7.

a) Copyright in broad terms

It is important to note at the outset that while it is not incorrect to refer to international copyright

law, it is nevertheless the case that there is no ‘international’ copyright right.99 Accordingly,

while numerous treaties exist providing recognition of and protection to copyright,100 such

rights are protected under the domestic laws of countries.101 Accordingly, copyright law has

99 See discussion in B Bodo et al, 'Blockchain and smart contracts: the missing link in copyright licensing?' (2018)

26 International Journal of Law and Information Technology 311, 320. 100 E.g. Berne Convention for the Protection of Literary and Artistic Works, Sept. 9, 1886, as revised at Paris on

July 24, 1971 and amended in 1979. 101 Bodo 2018 (supra, n 99). Such protection is bolstered by the requirements of the World Trade Organisation,

General Agreement on Trade-Related Aspects of Intellectual Property, 1869 U.N.T.S. 299

33 I.L.M. 1197.

24

not been fully harmonised, either at the international level, or within the EU,102 although the

Berne Convention, for example, does set down some general principles applicable to copyright

law. Copyright protected works must be original. ‘Ideas’ are not protected by copyright;103

rather, it is the expression of an idea that is the subject of protection. The minimum term of

protection accorded by copyright is the author’s life plus 50 years, or 50 years if the author is

not a natural person. Many countries, including those of the EU, have periods in excess of this

minimum.

b) DSI and copyright – understanding the context

Discussions on the potential application of copyright to genetic sequences have been ongoing

for over 30 years.104 To the extent that proponents of copyright protection for genetic sequences

anticipate important benefits to innovation from the application of such protection, copyright

is depicted as having many advantages over other forms of intellectual property protection such

as patents.105 As will be explored more fully below, the monopoly right granted to patent

holders may prevent follow-on innovation in respect of a genetic resource and thereby inhibit

scientific research and development. In addition, recent court decisions have created significant

uncertainty as to the legal protection provided by patent law to certain genetic resources.106 By

contrast, and as will be discussed below, copyright offers a range of exceptions and provides

greater scope for follow-on innovation than is the case with patent protection. A sui generis

system inspired by copyright could potentially draw inspiration from such protections, as well

as the more nuanced approach offered by copyright so as to better be able to reflect the different

societal and policy needs at the heart of the DSI debate.107

If concern for DSI reflects the so-called ‘dematerialisation’108 of genetic information, the

potential application of copyright to DSI is a mark of the so-called ‘new’ materialist movement

which seeks to highlight the, “the qualities and characteristics originating from non-human

actors’ such that, ‘the scope of original expression beyond that which originates with a human

contributor, might result in an expanded incidence of authorship.”109 In essence, by focusing

upon the agency of non-human actors, “the human contributor might be considered more of a

102 Though there are elements of harmonisation within the EU i.e. the Directive 2001/29/EC of the European

Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related

rights in the information society [2001] OJ L167/10. 103 Though ideas may attract patent protection. 104 See, for example, D L Burk, ‘Copyrightability of Recombinant DNA Sequences’ (1988 to 1989) 29 Jurimetrics

Journal 469 and I Kayton, ‘Copyright in Living Genetically Engineered Works’ (1982) George Washington Law

Review 191. 105 See, for example, discussion in N Lucchi ‘Genetic Copyright: An Alternative Method for Protecting and Using

Essential Public Knowledge Assets?’ (2018) 40 European Intellectual Property Review 766. 106 Ibid. 107 Ibid. 108 See, for example, M A Bagley, 'De-materialising genetic resources: synthetic biology, intellectual property and

the ABS bypass' in Charles R. McManis and Burton Ong (eds), Routledge Handbook of Biodiversity and the Law

(Routledge, 2017), Chapter 15. 109 Burk, Dan L., 'Copyright and the new materialism' in Jessica C. Lai and Antoinette Maget Dominice (eds),

Intellectual Property and Access to Im/material Goods (Edward Elgar, 2016), Chapter 2, 61.

25

curator or steward for the assemblage of actors who contributed to the creative result”110 which

copyright could protect. Here, the ‘creative result’ would be the genetic outputs of nature.

c) Reimagining copyright protection?

To date copyright protection has not in general been extended to DSI.111 Numerous

commentators have nevertheless posited that copyright is indeed flexible enough to “handle

contemporary technologies that produce living organisms or organic components, but

contemporary judges, practitioners, and scholars must reframe and, in some instances,

reimagine the proper contours of copyrightability in order to bring living works under copyright

protection."112 Numerous commentators, however, have in general rejected the notion that

copyright protection could apply to naturally occurring DNA sequences.113

Some commentators have expressed concern that copyright – and arguably by extension, a sui

generis system based on copyright - is a ‘poor fit for synthetic biology’ as there is little scope

for an author’s expressive choices.114 In essence, if the central premise of copyright is

protection of originality, what scope would there be for originality of expression in respect of

the generation of DSI from naturally occurring sequences? Holman, for example, argues that

copyright protection for DSI will likely depend upon the element of creativity present in a

sequence. By extension, in his view, any extension of copyright protection to what he terms

‘genetic code’ would need to be justified on public policy grounds. For Holman, optimal

innovation policy, “would likely impose some sort of requirement that, in order to be

copyrightable, a synthetic sequence must incorporate some significant degree of variation

relative to the closest naturally-occurring counterpart.”115

However, Holman’s view of public policy does not include considerations of the objectives of

the CBD or the Nagoya Protocol, which could undergird policy arguments in favour of the

creation of a sui generis regime inspired by copyright law to provide protection for naturally

occurring genetic sequences. Such a scheme would reflect the objectives of the CBD with a

view to rewarding provider countries for their contribution to biodiversity. Broad acceptance

of the need to prioritize these public policy objectives can be justified on the basis of the

alarming findings on the unprecedented rate of biodiversity loss and its wide-ranging

110 Ibid, 61 111 Though this is not to say that companies have not tried to assert copyright over DSI; our thanks to Paul Oldham

for this insight. 112 M D Murray, 'Post-Myriad Genetics Copyright of Synthetic Biology and Living Media' (2014) 10(1) Oklahoma

Journal of Law and Technology 1, 8. It is notable that copyright has been ‘reframed’ over the years to extend

protection to software which has been analogised to genetic ‘code’ by certain commentators such as R Neethu.

'Rethinking the debate on genetic copyright in Europe in the era of biobanks and synthetic biology' (2018) 40 (3)

European Intellectual Property Review 172. See also A Torrance, ‘DNA Copyright’ (2011) 46 Valapraiso

University Law Review 1; A Torrance and L Kahl, ‘Bringing Standards to Life: Synthetic Biology Standards and

Intellectual Property’ (2013) 30 Santa Clara High Technology Law Journal 199, pp. 226-227 and Rai and Boyle

2007 (supra, n 10). 113 See, for example, Murray, ibid. 114 Bagley 2017 (supra, n 108). 115 C Holman, 'Charting the Contours of a Copyright Regime Optimized for Engineered Genetic Code' (2016)

available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2833948, accessed December 2019, 21.

26

implications for human well-being in the 2019 Global Assessment of Biodiversity and

Ecosystems Services.

d) A sui generis system inspired by copyright: the example of annotation?

In the previous section, concerns were raised regarding the potential need for originality in any

sui generis system for DSI inspired by copyright. While it is possible this requirement could

be abandoned under a sui generis system, it is worth considering whether there are already

potential mechanisms under the existing copyright systems which could address this

requirement, so the link with copyright is more pronounced. For instance, some commentators

such as Zhuang have posited that such originality may arise from annotation. In essence,

Zhuang opines that, “the major challenge of 21st century genetics is annotating and

understanding genes’ functions and structures, rather than determining their DNA

sequence.”116 For example, proteomics experiments produce large quantities of data which

require to be interpreted so as to ascertain the relevance from a biological standpoint of any

identified proteins.117 Functional annotation of proteins is hence as significant as the

identification of the protein itself.118 Accordingly, it is the ‘informational annotation’ of a

sequence which is of value119 with such annotation reflecting the geneticist’s expressive

choices.120 Hence according to Zhuang, “when describing a gene, a geneticist selects and

arranges from (a) vocabulary an expression that forms a genetic copyright.”121 This

arrangement and the expressive choices involved therein would seemingly fulfil the

requirements of originality under copyright law. An agreed vocabulary would also help to

facilitate the implementation of a genetic copyright regime with such copyrights then requiring

registration to assist in enforcement.122 In line with the usual application of copyright law,

independent creation of an identical annotation would not result in infringement. Numerous

exceptions also exist under copyright to provide for a balance between protection and use.123

The regime envisaged by Zhuang would also allow others to use the underlying gene since

what is protected is the expression; that is, the annotations of the gene can be the subject of

copyright protection, not the underlying ‘idea’ behind that expression which in essence is the

gene itself.124 This would allow ‘improvements’ to be made to the ‘idea’, in contrast to the

patent regime which does not permit follow-on improvements to patented inventions.125 A

regime inspired by copyright could therefore potentially safeguard, recognize and encourage

follow-on innovation, thereby ensuring a better balance in terms of societal interests. However,

it is also the case that such a regime might favour researchers and companies who do the bulk

116 J J Zhuang, ‘Copyright: Better Fitting Genes’ (2015) 97(3) Journal of the Patent and Trademark Office Society

442. 117 C M Carnielli et al, 'Functional annotations and biological interpretations of proteomics data' (2015) 1854

Biochimica et Biophysica Acta 46. 118 Ibid. 119 Zhuang 2015 (supra, n 116) 449. 120 Ibid, 450. 121 Ibid, 450. 122 Ibid, 452. 123 Ibid, 456 – 457. 124 Ibid, 458. 125 Ibid, 458 – 459.

27

of annotation. To the extent that it may be said there is a technological divide between the

Global South and the developed world, this could lead to inequitable results.

Ultimately, Zhuang’s proposed genetic copyright system which would protect highly annotated

sequences has a certain merit. But it would not directly address the claims of provider countries

in respect of DSI generated from genetic resources in their territory, since the ‘idea’ – that is,

the ‘raw’126 as opposed to ‘curated’127 genetic information itself – would not be protected. In

essence, it is the ‘creative effort’ that would be rewarded, not the rights of provider countries.

Nevertheless, this proposal demonstrates the potential merit of relying on existing approaches

from copyright to respond to particular issues in the context of DSI.

(e) A sui generis system of protection based on the rights of provider countries?

The application of a regime inspired by copyright to DSI could potentially provide further legal

recognition of the sovereignty claims of ‘provider’ countries over such information, allowing

a degree of control as well as monetary benefit-sharing in the form of royalties from licensing.

The idea here would be that countries of origin of genetic resources would hold rights similar

to copyright over DSI for a certain period of time under a sui generis system of protection

inspired by copyright. Sui generis systems of intellectual property rights protection are not

unusual and have been implemented in instances under which existing systems of rights

protection were not able to address adequately particular sectoral needs.128 Examples include

sui generis database protection,129 as well as a sui generis system of plant variety protection

specifically envisaged under Article 27.3(b) of the WTO TRIPS Agreement although these

systems are designed to protect the rights of individuals, per se, as opposed to the rights of

States.

In respect of the application of a sui generis system inspired by copyright to provide legal

recognition of the claims of ‘provider; countries, a major concern arises regarding the need to

address the complexity of ‘shared’ sequences for which there may not be a single ‘provider’

country. In essence, and as discussed above, where sequences are shared between countries,

the idea of a ‘provider’ country becomes more problematic, particularly in the context of a

regime drawing inspiration from intellectual property. In essence, questions of valuation

(discussed above) would abound under such a system and it is difficult to see how these would

be overcome. In addition, issues of tracking would inevitably arise. While watermarking of

sequences could in principle allow for tracing,130 and likely satisfy the requirement of original

126 Laird and Wynberg 2018 (supra, n 5). 127 Laird and Wynberg 2018 (supra, n 5). 128 Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and

Folklore, Elements of a Sui Generis System for the Protection of Traditional Knowledge (WIPO/GRTKF/IC/3/8,

2002)> accessed December 2019. See also discussion in A Chander and M Sunder, ‘The Romance of the Public

Domain’ (2004) 92 (5) California Law Review 1331, 1355. 129 See e.g. Directive 96/9/EC on the legal protection of databases [1996] OJ L 77/20. 130 For further analysis, see N Yamamoto et al, 'A watermarking system for labeling genomic DNA' (2014) 31

Plant Biotechnology 241,

https://www.jstage.jst.go.jp/article/plantbiotechnology/advpub/0/advpub_14.0609b/_article/-char/ja/, accessed

October 2019.

28

expression such as to attract protection (assuming the requirement for originality is retained),

in practice it would not be cost-effective to watermark large amounts of DNA.131 In addition,

such watermarks can be subject to degradation through naturally occurring mutation and at this

point in time are not considered a viable or realistic option.132

A separate concern arises from the fact that a sui generis system based on copyright to

recognise and reward provider States would also need to respond to the different needs of

groups of users of DSI, particularly given that many databases containing DSI are in the ‘true’

public domain133 with any subsequent restrictions such as costs imposed on such information

risking a potential impact on biotechnological innovation in areas such as health, agriculture

and biodiversity conservation itself.134 As James Boyle has opined, “enclosure of the

information commons clearly has the potential to harm innovation as well as to support it.”135

Indeed, it is to be noted that the scientific and legal communities have long expressed concern

regarding the potential negative impact of IP rights on innovation. Numerous efforts have

therefore been made to innovate around ‘patent thickets’ that seemingly privilege large

companies and may lock out individual researchers and small companies - including those in

the Global South.136 So a proposed sui generis system should take into account the lessons

learnt about actual and potential negative impacts on innovation, including unequal impacts on

researchers in the Global South, particularly when they are contributing to biodiversity

conservation.

f) A broader system encompassing the range of actors along the DSI value chain?

Taking into account the preceding discussion, there may be merit in exploring the creation of

a sui generis system of copyright-like protection for DSI which is capable of responding to the

variety of needs, and recognizing the various contribution, of different actors all along the DSI

value chain: recognition of the ‘provider country’ for its contribution to conservation of

biodiversity – while noting the complexity of sequences ‘shared’ between countries - the

scientist who assembled the sequence, who annotated it, who genotyped, who aggregated the

data as well as potentially the database manager,137 thereby providing a system that can be

responsive to the different ‘creators’ of DSI. Such a system could draw on the operation of the

bundle of rights applicable to the musical context.

This context is particularly relevant since it gives explicit recognition to the contribution of the

different actors involved in music production with the copyright which affixes to the

131 M A Bagley, Digital DNA: The Nagoya Protocol, Intellectual Property Treaties, and Synthetic Biology

(Wilson Centre, 2016), 12. 132 Ibid. 133 Laird and Wynberg 2018 (supra, n 5), 45. This is to be contrasted with an open source approach whereby

conditions may be attached to the use of such information. 134 See generally Laird and Wynberg 2018 (supra, n 5) on the use of DSI. 135 J Boyle, ‘The Second Enclosure Movement and the Construction of the Public Domain, in James Boyle (ed),

Collected Papers: Duke Conference on the Public Domain (Center for the Public Domain, 2003) 33, at 44. 136 See generally Jerome H Reichman and Ruth L Okedji, ‘When Copyright Law and Science Collide:

Empowering Digitally Integrated Research Methods on a Global Scale’ (2012) 96 Minnesota Law Review 1362. 137 Albeit that the database may itself enjoy intellectual property protection already; see e.g. Directive 96/9/EC on

the legal protection of databases [1996] OJ L 77/20

29

composition of a piece of music, for example, distinct to the sound recording copyright which

typically resides with the production company. Performances of musical works can also attract

performance rights protection, with such performance rights existing in addition to any

underlying right(s) in the musical piece itself.138 Accordingly, a range of models could

potentially be analogised from, in order to design a sui generis system of copyright-like

protection for genetic resources capable of taking into account the contribution of different

actors along the DSI value chain. This seems particularly promising with a view to addressing

equity issues for researchers in the Global South and recognizing their contributions to

biodiversity conservation. Copyright may in effect be considered more suited than other

forms of intellectual property protection such as patents to provide a nuanced approach to

protection in that numerous exceptions exist to copyright which would arguably allow for a

variety of uses of protected sequences- such as for use in instruction and non-commercial

research,139 which contribute to biodiversity conservation. Furthermore, consideration could

be given to disaggregating the copyright inspired bundle to address different kinds of DSI, with

sectoral approaches also possible.

It must, however, be acknowledged that the large number of actors involved in DSI ‘creation’

would require more in-depth study of how best to operationalise such a scheme without it

becoming so complex that the costs of its operationalisation outweigh the benefits. In addition,

the impact of any new system, particularly upon innovation globally (and the need to foster

cooperation in innovation along the DSI value chain across Global North/South), needs

carefully considered. One particular concern that might arise is the very long period of

protection normally applicable to copyright although a sui generis system of copyright-like

protection could arguably deviate from this long period of protection since140 it could be

designed to fall outside the scope of existing copyright treaties.141 There may also be a benefit

to exploring other approaches to managing the relationship between providers/‘creators’ and

different types of users such as that encompassed within the open software movement, which

is underpinned by the impetus to promote both the “freedom to operate and freedom to

cooperate.”142

On the whole, there is much potential for the above-described system, which focuses on the

potential for a layered, sui generis approach to DSI inspired by copyright that recognises the

range of ‘creators’ involved in the ‘production’ of DSI. Much more analysis and discussion,

however, is needed to make sure that such a system effectively and fairly addresses the

concerns of Parties regarding the role of DSI in achieving the objectives of the CBD and

possibly also recognising Parties’ and Global South researchers’ contributions to biodiversity

conservation. Accordingly, this is not be an approach that we would recommend on its own,

138 T Iverson, ‘Original compilations of musical works: can DJ sets be protected by copyright?’ in Enrico Bonadio

and Nicola Lucchi (eds), Non-conventional copyright (Edward Elgar, 2018) 201, 211 139 Welch 2017 (supra, n 18), 22 - citing Torrance 2011 (supra, n 109). 140 Holman 2016 (supra, n 115), 30 to 31. 141 It would also arguably fall outside the scope of the TRIPS Agreement. 142 Laird and Wynberg 2018 (supra, n 5), 37, though see generally 36-38 on open software.

30

but could be part of a hybrid system (option 7) as the proposed dialogue platform (option 6)

could provide a forum to assess options in a generative and iterative manner.

g) Operationalisation

Regardless of the scope of a copyright-inspired sui generis system for DSI, that is, whether it

solely focuses on Parties’ contribution to DSI, or takes a more layered approach, in order to

function effectively, any such regime would need to be accompanied by some sort of licensing

system to ensure a degree of control over the sequence(s) as well as payment of royalties. As

described in option 3 above, blockchain, together with smart contracts, could be utilised here

to ensure a ‘quasi-immutable’ record of initial ownership143 together with speedy and efficient

licensing arrangements. This would, in effect, allow for a ‘private ordering’ of copyright.144

However, as discussed previously, a blockchain based system may in practice prove difficult

to operationalise due to the lack of incentives for users not to remove information from the

blockchain.145 However, the advantage of a copyright-like system is that incidences of

‘cheating’ may be subject to the remedies for infringement available under copyright law such

as monetary and equitable relief.

As a way to overcome the above identified problem, suggestions have been made to draw on

the so-called platform economy and develop a Netflix or Spotify-type bundle for DSI which

could be supported by subscription fees.146 In essence, this model would support highly curated

and/or annotated DSI, for which users would pay subscription fees to access. This ‘club type’

model has been proposed by Correa in respect of access to plant genetic resources for food and

agriculture (‘PGRFA’) in the Multilateral System (‘MLS’) with those accessing the system

paying an annual fee corresponding to, for instance, 0.2% of their annual seed sales of species

in the MLS.147 A subscription system for access to DSI could potentially see the fees

redistributed to States as rights holders as a type of monetary benefit-sharing for access to such

resources though, as noted above, the bulk of country-tagged NSD deposits to the INSDC are

from 4 countries – USA, China, Canada, and Japan which together account for more than 50%

of country-tagged NSD.148 Accordingly, it is not altogether certain that monetary benefit-

sharing to ‘rights’ holders in this context would benefit mega-diverse countries. In addition,

such a system, if applied to the broad range of DSI within scope, would be well beyond the

realms of financial feasibility as it would require a vast range of bioinformatics tools in order

to have any value to users, and would need to be a closed system (otherwise, why pay?), raising

costs further.149 Concerns might also arise as to how to distinguish between different categories

of users such as students, researchers from the Global South, as well as non-commercial users

143 See discussion in Bodo 2018 (supra, n 99). 144 Ibid. 145 See option 3 above. 146 Rohden at al 2019 (supra, n 46), 51. 147 C M Correa, ‘ITPGRFA: Options to Promote the Wider Application of Article 6.11 of the SMTA and to

Enhance Benefit-Sharing Legal Opinion’ (Berne Declaration, 2013)

https://www.utviklingsfondet.no/files/uf/documents/ITPGRFA_Legal_opinion_2013.pdf, accessed October

2019. 148 Rohden et al 2019 (supra, n 46). 149 Rohden et al 2019 (supra, n 46), 51.

31

more general – so consideration needs to be given to how this approach would effectively

support biodiversity conservation.

Other potential options include requiring users to agree to specific licensing conditions –

including, where relevant, payment of remuneration – upon access to certain databases.

Sectoral/tailored approaches could be utilised here to ensure fine-tuning of agreements in

accordance with the type of DSI/sector. Licenses could, for example, be designed to reflect

the class of user with different licenses, for example, applying to commercial and non-

commercial use.150

In respect of the above, conditions of use notices and click-through agreements requiring users

to confirm agreement to certain conditions when accessing DSI via specific databases are not

uncommon, but it is unclear to what extent such conditions are adhered to.151 While there may

be ways to ensure greater attention of, and adherence to, the likes of click-through

agreements,152 these would need to be accompanied by traceability mechanisms (see option 3

above) to reduce incentives to cheat, as well as ensure payment of royalties. Inserting licenses

at the point of access to a database would also require significant interaction between rights

holders and databases for such a system to function effectively and there would need to be

greater interoperability between databases. States as rights holders could, however, be

represented collectively so as to reduce associated transaction costs. Inspiration could be drawn

here from the private sector with organisations such as Broadcast Music Inc. (BMI) and the

American Society of Composers, Authors and Publishers (ASCAP) which currently offer rights

management services in the music domain.153 As outlined above, however, these would not

remove the need for enhanced systems of traceability to ensure licensing conditions are adhered

to. It is also an open question to what extent publicly available databases such as those under

the INSDC would be willing to include licensing conditions for database access with anecdotal

evidence suggesting that this idea would not be popular. In addition, the INSDC is publicly

financed by the US, EU and Japan and so it is not altogether clear to what extent adding another

layer of costly complexity to the system would be supported without defined and demonstrable

benefits being established in advance. Without further in-depth study into the costs and benefits

of such a system, it is difficult to make a more definitive assessment.

h) States’ rights under a domaine public payant model

Another possibility to protect States’ rights in a copyright-like approach is to draw inspiration

from the concept of domaine public payant, which has already explored in the context of

cultural heritage. In essence, “this principle applies to works that have lost copyright protection

and are in the public domain but for some reason are deemed important enough to receive

special attention that is expressed in the obligation to pay the state … a fee for the use of these

There are no sources in the current document.150 For an insightful commentary on different licensing

arrangements, see P Oldham, ‘An Access and Benefit-Sharing Commons? The Role of Commons/Open Source

Licenses in the International Regime on Access to Genetic Resources and Benefit Sharing’ (Secretariat to the

CBD, 2009) UNEP/CBD/WG-ABS/8/INF/3. See also Laird and Wynberg 2018 (supra, n 5). 151 Laird and Wynberg 2018 (supra, n 5), 36. 152 Ibid. 153 Holman 2016 (supra, n 115), 32.

32

works, crafts and arts.”154 The domaine public payant, or the “paying public domain” aims to

ameliorate the “harm caused by creating property rights over the common (cultural) pool from

which society draws, but at the same time, it imposes certain conditions on the use of works in

the public domain … (such as) the payment of fees.”155 Applied to the DSI domain, what we

term the digital domaine public payant, would recognise that DSI should not be treated as a

freely exploitable resource,156 but rather regulated as a semi-commons underpinned by the

principle that a fee should be paid in recognition of provider countries’ contribution to

biodiversity and in order to support the objectives of the CBD.157 This logic is based on a

combined and integrated reading of the objectives of the CBD and the global recognition of

their relevance for the realization of the SDGs, so the criteria for selecting which material is

subject to payment is related to the CBD subject matter and global public policy objectives that

depended on the effective implementation of the CBD.158 The digital domaine public payant

could be multilateralised with funds disbursed in accordance with CBD objectives, so as to

remove the issues with tracking and tracing as well as valuation identified above as problematic

(see option 7 below). The potential for a multilateral approach is outlined in option 5 below.

Examples of the domaine public payant in the cultural heritage sector can be found at national

level, which reveal some operational matters that need to be considered, should the approach

be extended to other contexts. Firstly, the domaine public payant applies to literary or artistic

works which are no longer copyright-protected but available in the public domain, with

payment due upon use rather than access, by major users rather than individuals such as

publishers, impresarios, record manufacturers, radio and television networks.159 Secondly, an

analysis conducted by WIPO in the 1980s, showed that some countries which apply the

domaine public payant required authorisation prior to use, or at least a declaration of use, but

international experts concluded that this was not a desirable approach in light of the inhibiting

effect on access.160 Furthermore, structural questions arise with regard to the authority that is

competent to collect and distribute fees, and the beneficiaries and types of funding provided.161

In Argentina, for example, payments received under the domaine public payant legislation is

154 M Ruiz Muller. 'Protecting Shared Traditional Knowledge: Issues, Challenges and Options' (2013) ICTSD

Issue Paper No. 39, 14. 155 L Lixinski, Intangible Cultural Heritage in International Law (Oxford University Press, 2013) 199. On the

domaine public payant, see also D J Gervais, ‘The Internationalization of Intellectual Property: New Challenges

from the Very Old and the Very New’ (2002) 12(3) Fordham Intellectual Property, Media & Entertainment Law

Journal 931, Giblin, R., 'Reimagining copyright's duration' in Rebecca Giblin and Kimberlee Weatherall (eds),

What if we could reimagine copyright? (ANU, 2017) chapter 6, D F Robinson, 'Is the Whole Greater than the Sum

of its Parts: A critical reflection on the WIPO IGC' in Charles R. McManis and Burton Ong (eds), Routledge

Handbook of Biodiversity and the Law (Routledge, 2017) chapter 23, C Mouchet, 'Problems of the Domaine

Public Payant' (1983) 8 Columbia Journal of Art and Law 137 and A Dietz, A Modern concept for the right of the

community of authors (domaine public payant) (1990) XXIV Copyright Bulletin 4. A useful overview is provided

in WIPO, Scoping Study on Copyright and Related Rights and the Public Domain' (2010)

CDIP/4/3/REV./STUDY/INF/1. 156 On a broader level, see J L Contreras, ‘Data Sharing, Latency Variables and the Science Commons’ (2010) 25

Berkeley Technology Law Journal 1601. 157 See generally Lixinski 2013 (supra n 155), 203. See also Ruiz Muller 2013 (supra, n 154), 15. 158 Ruiz Muller 2013 (supra, n 154) 14. 159 Mouchet (supra, n 155). 160 WIPO-Berne Union, ‘The “Domaine Public Payant”’ (Copyright, 1982), available at <

https://www.wipo.int/edocs/pubdocs/en/copyright/120/wipo_pub_120_1982_06.pdf> accessed March 2020. 161 Ibid, p 182.

33

the only source of income for the Fondo Nacional de las Artes and uses it to provide loans to

authors and artists, finance exhibitions and awards or fellowships.162 Other operational aspects

that have been considered at international level and within legal scholarship concern the types

of works that are covered, temporal and geographical scope and the method to calculate fees,

with discussed options varying from lump-sum payments to proportional revenue levies.163

Such considerations would also very much apply in the DSI context; most particularly in

respect of the questions of how (and arguably when?) should fees be paid and who should

disburse funds and to whom and indeed, for which purposes. We return to these issues in our

discussion in option 7 (below).

While more in-depth study is needed to understand the opportunities to that arise from adoption

of a multilateralised digitial domaine public payant approach to monetary benefit-sharing for

DSI, its value for moving the current debate towards multilateral solutions is that it can take

into account both the practical challenge that sequences may be common to a number of

countries and the principled issue of ensuring realization of the CBD objectives and contribute

to multiple SDGs is significant. As we discuss below, such an approach would be best

accompanied by a forum for dialogue and learning – what we term the hybrid approach set out

in option 7 - and so we explore further in option 7 possible options for operationalisation of the

digitial domaine public payant.

To sum up, a sui generis regime inspired by copyright could potentially have a number of

attractive features such as, 1) recognizing and rewarding the contribution of States that

conserve biodiversity on the basis of which DSI is generated; and 2) recognizing more

equitably the contributions of researchers in the Global South to the conservation of

biodiversity in their own countries and responding to their needs to collaborate with other

innovators along the DSI value chain. But it would likely encounter practical problems in its

operation, including those relating to practicality and cost. Licensing of such a system would

require considerable engagement with database managers and greater interoperability between

databases. Issues with tracking and tracing would also need to be resolved before such a regime

could be entered into and the problems of valuation of monetary benefits outlined in option 3

above also remain. Indeed, the problem of valuation seems to militate against any system for

DSI based upon a bilateral logic. Concerns also surround the likely costs and benefits of

introducing such a complex system. In addition, it would be necessary to assess to what extent

a sui generis copyright-like regime may create equity issues for innovators in the Global South

and how it could be best contribute to biodiversity conservation. For these reasons, a sui

generis system of copyright-like protection might be best encompassed within a hybrid

system which moves away from the bilateral logic of exchange and instead takes a multilateral

approach whereby payment is via a multilateralised digital domaine public payant,

accompanied by a platform focused upon dialogue and learning in direct engagement with a

wide range of stakeholders such as database operators, researchers, innovators and funders (see

option 7). However, as noted above, before anything this complex is embarked upon, extensive

162 See notably the unpublished work by Maximimliano Marzetti on this topic (e.g. PhD Dissertation - The Law

and Economics of the ‘Domaine Public Payant’: A case-study of the Argentinian system). 163 WIPO Report (supra n 160), pp 182-183.

34

studies of cost/benefit, as well as practicality, must be undertaken. As a preliminary step to

this, however, we explore the potential benefits of a multilateral approach in the next option.

35

Option 5: A multilateral fund

In our above discussion (options 1 to 4), we discussed possible options for accommodating DSI

within a bilateral framework. However, we identified a number of practical issues arising from

the application of such bilateralism. We also honed in on important issues of equity associated

with DSI. In essence, if sequences may be common to a number of countries, would application

to DSI of the current bilateral ABS approach support fairness and equity in benefit sharing or

even work at all?164 Accordingly, while blockchain technology, smart contracts and other

mechanisms to monitor and track DSI are theoretically possible, and a copyright inspired

system for DSI could build upon such mechanisms, they do not address issues of fairness and

equity associated with the current bilateral ABS system.165 We therefore need to scrutinise how

a multilateral approach to monetary benefit-sharing could potentially deal with DSI under the

CBD and Nagoya Protocol.

In this section we examine certain options for accruing monetary benefits generated from the

use of DSI obtained from genetic resources into a multilateral fund for them to be subsequently

distributed among Parties.166 We examine a menu of options to multilateralize the sharing of

benefits associated with DSI. It is likely that several of the options discussed here could be

combined as part of a broader system or as part of a phased or stepwise approach to DSI.167

Accordingly, the options discussed below should not be considered as mutually exclusive.

They could also be useful as part of a sectoral approach to DSI and in certain instances, we

draw on existing sectoral approaches for the purpose of inter-regime learning.

It should further be noted that while our focus here is on monetary benefit-sharing, it is also

the case that there is something of a false dichotomy between monetary and non-monetary

benefits, because non-monetary benefits have costs and economic value.168 For instance,

sharing raw data on marine genetic resources as an open access resource still requires the

development of adequate infrastructure and curation; training has costs related to trainees’

travel, precious space/resources on expensive scientific research vessels, trainers’ time, and

scholarships; and the sharing of best practices requires analysis and effective delivery of

information. This is discussed further below (option 6 below).

After exploring the functionality of a variety of funding options based on the experience of

existing multilateral funds, including those responsible for multilateral monetary benefit-

sharing mechanisms (on the side of accruing benefits and that of distributing benefits), we

move on to assess issues pertaining to governance and accountability which should be

considered in respect of any multilateral benefit-sharing fund, providing an assessment based

on the experience of existing multilateral monetary benefit-sharing mechanisms and funds.

Finally, we discuss a possible site of a multilateral fund, exploring the pros and cons of different

arrangements. In this regard, we discuss three possible approaches (1) a multilateral approach

164 See discussion above under ‘core assumptions and summary of findings’. 165 See generally Ruiz Muller 2018 (supra, n 25), 11. 166 Bagley 2016 (supra, n 131) 12. 167 See discussion below at option 7. 168 Ibid.

36

based on Article 10 of the Nagoya Protocol 2) a global fund for biodiversity under the CBD

(and therefore centred under the UN system) and (3) a global fund for biodiversity outside of

the existing ABS system. We conclude this section with a summary and develop a number of

principles which should be considered in the development of such a fund and propose the CBD

as the appropriate site of governance for such a fund, while recognising that a more thorough

review and research process would be needed to understand the costs and benefits of a

multilateral approach, whether under the CBD or elsewhere.

In addition, there are several lessons learnt in multilateral funds in other sectors that can be

built upon in the context of DSI. For instance, disbursement of funds should be done in

accordance with defined criteria agreed in advance with a range of applicable stakeholders, so

that benefit-sharing effectively contributes to the holistic realization of the CBD objectives and

relevant SDGs. In addition, careful consideration should be given to the design of governance

structures to ensure equity and create opportunities for learning and iterative design to make

sure that the fund really responds to beneficiaries’ needs and evolving scientific practices.

On the whole, we favour the establishment of a multilateral fund under the CBD (as part

of a hybrid option, as explored in option 7) because sustainability and predictability of

funding is a precondition for well-functioning benefit-sharing mechanisms.

Before we move on to discuss our proposed multilateral approach to monetary benefit-sharing,

an important caveat is in order. As set out above (option 2 above), the recommendations made

in this study extend to DSI in public databases, with private databases likely to be governed by

the Nagoya Protocol and mutually agreed terms. Accordingly, whereas public databases could

ultimately be governed by the multilateral approach set out below, private databases would

need to be governed by the Protocol. As discussed previously, DSI from public databases,

would benefit for further study in this regard.

a) Funding – accrual of benefits

In establishing any new multilateral benefit-sharing arrangement, the resources required to

operate such a mechanism should be both “sustainable and embedded in the system itself.”169

While these costs will obviously differ depending upon the nature of the arrangement in

question, our examination of potential funding options is underpinned in particular by a

concern for financial sustainability. We are also cognisant of the risk that creating an additional

multilateral fund for DSI/biodiversity more generally could result in competition with other

environmental funds, as well as undermine other – non-monetary – benefits. We therefore take

these concerns into account where relevant.

i. A tax or levy

We may draw inspiration from the literature on traditional knowledge (TK), in respect of which

a number of proposals have been made to deal with shared and widely disseminated TK. An

analogy may be made here with DSI. For TK, a small fixed fee imposed on certain products

169 Ruiz Muller 2013 (supra, n 154) fn 30.

37

such as biotrade products has been proposed with the idea that this could contribute to an

international compensatory fund. This could then be used to fund projects aimed at

conservation and sustainable use in certain areas of the world defined in advance.170

Based on the above, it is thus worth considering whether a tax or levy might be attractive to

deal with DSI. In this regard, Winter has proposed a similar mechanism which he terms a

‘biodiversity charge.’171 Under his proposed scheme, “any remuneration for the sales of a

product, for a patent or breeder’s license or for the rendering of a service would be subject to

the payment of a tax if the value-generating object or activity is based on genetic resources (or

TK).”172 This tax would be paid into a worldwide fund for further dissemination according to

predefined criteria. Such a tax/fee could also cover material considered to be out of scope of

the Nagoya Protocol (i.e. material accessed in all Parties, including those that have not

legislated on access, derivatives, and any information generated from natural resources).

Clearly, the scope of this proposal is broader than that envisaged above in that it applies to

different economic sectors, not only the sale of goods and would apply to all products to which

the ‘value-added’ is generated from a genetic resource (or TK). A further option would be to

extend the tax/levy to include activities such as mining, logging, industrial agriculture, and oil

exploration since these activities cause significant damage to biodiversity.

What is clear from the discussion of the option to impose a biodiversity tax is that considerable

thought would need to go into the appropriate legal vehicle to implement such a charge on a

multilateral basis so as to ensure fairness and equity. Regardless of the scope of such a tax,

there would likely be a need to differentiate between countries, goods and in this case sectors

in the application of such a tax/fee. A binding international treaty would arguably be the first

best option to ensure compliance although of course such a tax would need to be established at

the national level, which presents difficulties in terms of its operationalisation.

An additional issue which needs to be considered is that a general biodiversity or biotrade

product tax, with expansive coverage beyond products derived from DSI, could be framed as

marking a fundamental break in the bilateralism of the CBD/Nagoya regime for all genetic

resources within scope – including physical samples - not just for DSI. On the one hand, some

commentators have noted that this would be potentially beneficial,173 and in one sense a move

beyond the current ABS system is inevitable if one recognises genetic resources as often widely

shared between jurisdictions. On the other hand, this would nevertheless require a fundamental

shift in paradigm which would need to be very carefully considered. It is also the case that

including material outwith the scope of the Nagoya Protocol may somewhat ameliorate this

risk. Additionally, and as mentioned above, there is also the potential to include extractive

170 Ibid, p. 15. 171 G Winter, ‘Knowledge commons, intellectual property and the ABS regime’ in Kamau; EC and Winter G

(eds), Common Pools of Genetic Resources Equity and Innovation in International Biodiversity Law (Taylor &

Francis 2013) 285, 298. 172 Ibid. 173 E C Kamau and G Winter, ‘An introduction to the international ABS regime and a comment on its transposition

by the EU’ (2013) 9 Law, Environment and Development Journal 106, 122.

38

industries within such a tax/levy which would both broaden its scope, as well as expand the

potential revenue stream of any such charge.

While the imposition of taxes/levies is expected to be unpopular and face resistance at the

international level, the imposition of levies within sectors to promote particular societal goals

linked to that sector is a well-established practice. The UK, for example, imposes an ‘apprentice

levy’ on employers with pay bills in excess of £3 million to fund apprenticeship training.174 A

biodiversity levy or tax would not just be another tax for revenue-raising purposes but rather

would be used to fund projects related to the conservation or sustainable use of biodiversity

and thereby contribute to relevant Sustainable Development Goals. Reconceptualising or

reframing the above discussed taxes/fees in this way may help such proposals to gain traction

though measure design will be key to acceptability as well as likelihood of success.

However, while reframing the issue undoubtedly makes conceptual sense, it is also the case

that in administrative terms, a tax/levy scheme would come with considerable challenges which

cannot simply be disregarded. It may be difficult to get multilateral buy-in for the proposition

of a tax, particularly given the costs of administering such a system, and its operation may

impact negatively on research, free exchange and collaboration. Accordingly, while, a tax/levy,

if properly designed, should in principle provide for the financial sustainability of such a

system, it is also the case that the practical operation of such a scheme, together with its impacts

upon particular sectors, needs carefully considered.

ii. A charge on commercial development

Numerous proposals have been advanced in the literature whereby an obligation to pay

royalties would attach to any IP, such as a patent, based upon based on DSI.175 Disbursement

of such royalties would be through a multilateral fund. Disclosure of the country of origin in

respect of patent applications using genetic resources has been implemented in numerous

countries and while certain commentators have raised the question of compatibility with the

TRIPS Agreement, it is notable that no disputes have been brought to the WTO dispute

settlement in respect of this practice.176 Another possibility is to follow the model of Brazil,

whereby a commercialisation charge of 1% is applied to all products “accessed Brazilian

genetic heritage, associated traditional knowledge, or that have commercially exploited final

products or materials derived (there)from.”177

174 See, for example, discussion in Dietz 1990 (supra, n 155), 21. 175 ‘Apprenticeship Levy’ (UK Government – Policy Paper, 2016)

https://www.gov.uk/government/publications/apprenticeship-levy/apprenticeship-levy, accessed December

2019. 175 M Ruiz Muller, ‘Access to Genetic Resources and Benefit Sharing 25 Years on’ (2018) ICTSD Issue Paper

No. 44. Recent developments in WIPO may make this process simpler; see also Rohden et al 2019 (supra, n 46),

44 to 45. 176 Bagley 2016 (supra, n 131) 16. 177 See M Brown, ‘New Brazilian Law on Genetic Heritage gives one year to companies to report on their past

activities having used Brazilian genetic heritage’ (Lexology, 2017)

https://www.lexology.com/library/detail.aspx?g=3f8fb766-b4f0-437d-80ee-ae2ee742f360, accessed December

2019.

39

It should be noted, however, that many genetic resources are shared by more than one

country,178 thereby raising equity concerns although there are ways to address this potential

problem, as was discussed above. One further issue that may be more difficult to address is a

more practical one; securing sustainable funding may be difficult when there will be a time lag

in respect of any commercialisation. Accordingly, payment of royalties based on

commercialisation may, at least initially, yield very little by way funding. By way of illustration

of this point, the ITPGRFA is currently reviewing the operation of its standard material transfer

agreement (SMTA) with a view to enhancing monetary benefit-sharing. This is due to a lack

of commercialisation, which has resulted in a reliance upon donations to fund the Treaty’s

Benefit-Sharing Fund.179 Charges based upon commercial development may therefore not be

the best option to ensure financial sustainability, though potentially this option could be

combined with others from the menu discussed here. A further practical concern may also arise

in that there may arise instances in which collections take place in a country and a direct link

is possible between the sequence and commercialisation. How such scenarios are dealt with

under a multilateral fund would need to be carefully considered.

iii. A subscription fee or one-off payment for access to DSI

A subscription fee or payment for access to DSI is a further potential way in which funds might

be raised for monetary benefit-sharing in respect of DSI. In addition to generating funds, a

subscription system can enhance legal certainty and reduce transaction costs due to removal of

the need to track and trace.180 Under this model, a subscription fee or one-off payment would

be required to access the numerous databases hosting DSI. However, while a number of

specialised databases do require payment,181 comprehensive public databases such as those

within the INSDC are free. Indeed, it is notable the emphasis placed within the INDSC’s policy

upon, “free, unrestricted access to all of the data records in their database.”182 Sectoral

approaches could work here, however, with a subscription system having been proposed in the

ITPGRFA inter-sessional process based upon upfront payments, “on the overall revenue

generated by crop(s) sales. Benefits are contributed to a global common pool in which

accumulated fund support select projects aimed at increasing capacity in member countries,

and achieving the Treaty’s overall objectives of food security and sustainable agriculture.”183

178 Ruiz Muller 2018 (supra, n 25). 179 Ruiz Muller 2018 (supra, n 25), 18. 180 For an overview, see E Tsioumani ‘Consensus Within Reach for Plant Treaty Working Group to Revise ABS

System’ (ISSC, 2019) https://sdg.iisd.org/news/consensus-within-reach-for-plant-treaty-working-group-to-

revise-abs-system/, accessed December 2019. 181 As noted by G Winter, ‘Knowledge commons, intellectual property and the ABS regime’ in Kamau; EC and

Winter G (eds), Common Pools of Genetic Resources Equity and Innovation in International Biodiversity Law

(Taylor & Francis 2013), ‘Traditional Chinese Medicine Database System, which compiles a large number of pre-

existing Chinese Medicines databases. Access is possible after registration and against an up-front payment, which

is used to cover the maintenance of the system. The user does not have to sign an agreement or disclose the aim

of use’ p 288, footnote omitted. Winter 2013, also notes that certain commercial databases such as BIOBASEW'S

TRANSFAC(r) charge a user fee with further restrictions on third party access and rights, 291. 182 Laird and Wynberg 2018 (supra, n 5), 29. 183 E Morgera, ‘Study on Experiences Gained with the Development and Implementation of the Nagoya Protocol

and Other Multilateral Mechanisms and the Potential Relevance of Ongoing Work Undertaken by Other

Processes, Including Case Studies’ (1-3 February 2016) UN Doc UNEP/CBD/ABS/A10/EM/2016/1/2, 20.

40

The design of any subscription fee applied to different sectors of DSI would need to take into

account the different economics underpinning particular sectors and be accompanied by a

nuanced/structured approach to respond to different types and uses of DSI with an emphasis

on supporting scientific cooperation for conservation and sustainable use of biodiversity.

Arguably, subscription fees, if viable at all, would best be discussed within the context of the

hybrid option 7, given its focus on learning and dialogue with stakeholders, and would

additionally require fees to be structured in such a way that students and researchers from the

Global South would either not pay for access, or would pay a reduced fee with a view to

supporting biodiversity conservation. The combination with a global platform for dialogue and

learning outlined in option 7 would also allow for adapting the fee system in light of growing

understanding and multilateral discussion of the different economics underpinning particular

sectors.

iv. Voluntary contributions

Voluntary contributions could be sought from states, database users and other actors (including

the private sector), which could be disbursed multilaterally. The WHO PIP Framework

Partnership Contribution is a potentially instructive in this regard. The Partnership Contribution

is paid by manufacturers of influenza vaccine, as well as diagnostic and pharmaceutical

manufacturers who use the WHO Global Influenza Surveillance and Response System

(GISRS). A questionnaire is sent by the WHO every year to potential contributors with the

funds then allocated to capacity building, pandemic response and maintenance of the PIP

Framework.184 A similar questionnaire to companies making use of publicly available

databases could seek donations to fund capacity building initiatives and biodiversity activities.

Governments could also be asked to contribute on a voluntary basis.

There are several counterarguments to the use of voluntary contributions on their own. First, it

is doubtful that the financial sustainability of a system can based solely upon donations. By

way of example, the Intergovernmental Science-Policy Platform on Biodiversity and

Ecosystem Services (IPBES) is severely underfunded.185 In that connection, there is also a

concern that the establishment of a new funding stream based on donations could result in

funding being pulled away from existing institutions. Second, voluntary donations are

unpredictable and effectively place the very existence of the system in the hands of donors,

thereby inherently raising equity and fairness concerns.

v. (GREEN)

Given doubts over the sustainability of certain of the options discussed above, more innovative

funding ideas may need to be pursued. A possible option here includes drawing on the Global

184 ‘Influenza – PIP Partnership Contribution’ (WHO, n.d.)

https://www.who.int/influenza/pip/partnership_contribution/en/, accessed December 2019. See discussion in M F

Rourke et al. ‘Access and benefit-sharing following the synthesis of horsepox virus’ (2020) Nat Biotechnol

https://doi.org/10.1038/s41587-020-0518-z. 185 G Futhazar, and others, 'The IPES, Biodiversity and the Law: Design, functioning and perspectives of the

Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services' in Charles R McManis and

Burton Ong (eds), Routledge Handbook of Biodiversity and the Law (Routledge, 2017), Chapter 27.

41

Fund for AIDS, TB and Malaria’s (RED) programme186 which receives funding for HIV/AIDS

specific programmes from goods sold under the (RED) badge.187 Brands involved in (RED)

include Apple, Starbucks, Beats by Dr Dre and Alessi. $600 million has already been raised

from this programme188 and there may be attractions in pursuing a biodiversity equivalent of

(RED). Accordingly, to the extent to which any multilateral benefit-sharing fund linked to DSI

converges into a broader fund funding projects linked to objectives such as conservation and

sustainable use, there may be merit in pursuing the introduction of a (GREEN) programme for

biodiversity to ensure diversity, and hence sustainability, of funding sources. Such a

programme would be applied to a subset of products sold on consumer markets and would

therefore not attempt to link with DSI-derived products, at least not in an explicit sense. A

(GREEN) fund could also have a wider purpose and act more broadly as a biodiversity resource

mobilisation tool, rather than seeking solely to address DSI.

vi. Biodiversity bonds

Long-term financial sustainability, as well as diversity of funding sources, may also be

achieved through the use of financial instruments such as a bond issue. For example, Gavi, the

Vaccine Alliance’s innovative International Finance Facility for Immunisations (IFFIm) allows

‘vaccine bonds’ – debt instruments – to be sold to investors.189 Donors are able commit to

financing over the longer term190 but funds are able to be raised in the short term.

A biodiversity bond could be issued and based on long-term financial pledges of donor states.

Alternatively, a biodiversity bond could provide financing in the short to medium term until

fees from commercialisation are realised, if this option is pursued.191 The risk profile of such a

bond issue, based upon long-term commercialisation hopes, is likely to be quite different to

that of a bond based upon donor commitments and this may impact upon the appetite of

investors for such a product. Furthermore, while the IFFIm works well192, other examples of

bonds being used to fund global issues such as the World Bank’s Pandemic Emergency

Financing Facility have been the subject of heavy criticism that it, “serves private sector

interests at the cost of global health security”193 so bond design will be crucial here. It is notable

that there is growing appetite to use bonds to secure finance to tackle global issues, with the

186 ‘Red’ (The Global Fund, n.d.) https://www.theglobalfund.org/en/private-ngo-partners/resource-

mobilization/red/ accessed December 2019. 187 See discussion S Sekalala, Soft Law and Global Health Problems: Lessons from Responses to HIV/AIDS,

Malaria and Tuberculosis (Cambridge University Press, 2017) 199. 188 Figure as of July 2019; see ‘Red’ (The Global Fund, n.d.) https://www.theglobalfund.org/en/private-ngo-

partners/resource-mobilization/red/ accessed December 2019. 189 K A Klock, 'International Public-Private Partnerships as Part of the Solution to Infectious Disease Threats:

Operational, Legal, and Governance Considerations' in Sam F Halabi (eds), Global Management of Infectious

Disease After Ebola (OUP, 2016) Chapter 9, 170. 190 See also discussion in L Gostin, Global Health Law (Harvard University Press 2014), Chapter 5. 191 Indeed, there has been a substantial increase of late in the so-called ‘green bond’ market: ‘Green Bonds’ (CBD,

n.d.) https://www.cbd.int/financial/greenbonds.shtml, accessed December 2019. 192 See discussion in Gostin 2014 (supra, n 190), 156 – 157. 193 B Brim and C Wenham, ‘Pandemic Emergency Financing Facility: struggling to deliver on its innovative

promise’ (2019) 367 BMJ I5719.

42

Crop Trust currently considering issuing Food Security Bonds194 to ensure the financial

viability of its trust fund.

b) Funding – disbursement of benefits

Disbursement of benefits under a potential multilateral benefit-sharing regime for DSI may fall

under at least two potential conceptual arrangements. The first is what can be termed a

compensatory liability regime. As we will see, under such a regime, an attempt would be made

to correspond the payments of benefits to providers of DSI195, although benefit-sharing would

not be done bilaterally but through a multilateral fund, thereby reducing transaction costs. The

linking of payments to provider countries could take a number of forms and would not

necessarily involve tracking DSI along the entire value chain. Such matching of benefits could

also take into account the transboundary nature of genetic resources so that benefits could be

shared between a number of countries sharing a specific genetic resource.

By contrast, under the second arrangement, the link between provider countries and eligibility

for monetary benefits would be replaced by a more general recognition of the ‘value’ of DSI –

as well as the contribution of provider countries to conservation – and the need for monetary

benefit-sharing. The second arrangement would in some ways involve a simplified architecture

and would likely support a project-based approach to benefit-sharing according to pre-defined

criteria.

Certain of the funding options explored above could be structured to fit within either of these

arrangements though certain more generalised funding suggestions such as donations as well

as creation of a (GREEN) brand more clearly fit within the second arrangement. A hybrid of

each of these arrangements is also possible. It is therefore to be emphasised that much like the

options for accrual of benefits discussed above, these arrangements should not be seen as

mutually exclusive.

Finally, we do not wish to present the idea that there should be a ‘one-size-fits-all’ approach

for a multilateral fund to address monetary benefit-sharing in relation to DSI. Even if this were

possible, there are immense variations in terms of the economics of different sectors and

(sub)sectors that need to be considered. More concretely, these variations, and the extent to

which they require different responses, mandate in favour of an in-built learning dimension

leading to iterative approaches to implementation (to be balanced against realistic approach for

users and legal certainty). The idea of an in-built learning approach to support iterative

approaches to benefit-sharing is presented in option 6 below, and the idea of a multilateral fund

and a multilateral platform (option 6 below) can be combined in the hybrid option (option 7).

i. Compensatory Liability Regime

194 See Intergovernmental Technical Working Group on PGRFA, ‘Report from the Global Crop Diversity Trust’

(FAO, 2018) http://www.fao.org/3/CA0107EN/ca0107en.pdf, accessed December 2019, 13. 195 As we see below, however, in respect of globally disbursed sequences/species, no such ‘matching’ of payments

would take place and instead, benefits would flow into a multilateral fund.

43

As should be clear from the name, a compensatory liability regime is a system based on liability

rather than property rights.196 Whereas a property regime ‘vests exclusive rights in owners’, a

liability regime operates according to a ‘use now, pay later’ principle whereby use of the

resource is permitted without explicit permission of the rights holder, provided compensation

is paid, although limits may be imposed on the use of the resource.197 Under such a regime,

DSI would be recognised as semi-commons (see also hybrid option 7).198

An example of a compensatory liability regime has been suggested by Ruiz Muller whereby

benefits are accrued based on the use of DSI in patents and disbursed to countries hosting the

species from which the genetic information was derived.199 He proposes utilisation of a

mechanism to determine geographical distribution of genetic resources such as the

International Barcode of Life Initiative could be utilised to assist in determining fund

distribution entitlements.200 For so-called globally disbursed species and sequences which

make up the greater percentage of species and sequences accessed for research and

development, there would be no payment to individual countries with royalties used instead to

fund the system.201202 This may in all events end up being a significant proportion of the overall

total. MAT/PIC would still be relevant to the sharing of non-monetary benefits203 in respect of

DSI extracted from genetic resources from provider countries.

The scheme outlined above has also been referred to as one centred on ‘bounded openness’204

whereby genetic resources would continue to flow freely but the operation of such a scheme

would be bounded in that it would not be free of cost.205 The proposals outlined above which

are based on the payment of royalties into a multilateral fund based on compensation for use

of DSI upon, for example, commercialisation would fall broadly under this category.

As should be obvious from the above discussion, the criteria by which funds are distributed

under a compensatory liability regime will ultimately be a strong determinant of its success.

Clear and transparent criteria will need to be developed in advance and in conversation with

relevant actors. Such an arrangement will undoubtedly be complex and may potentially raise

equity concerns regarding the capacity of relevant actors to contribute to the conversation.

Furthermore, where funding is limited this may cause competition between parties, particularly

196 See discussion in G Dutfield, ‘Protecting Traditional Knowledge and Folklore: A review of progress in

diplomacy and policy formulation' (2003) UCTAD-ICTSD Project on TRIPS and Sustainable Development Issue

Paper 1, 9. 197 Ibid, 40. 198 See generally ibid. See also J H Reichman and T Lewis,’ Using Liability Rules to Stimulate Local Innovation

in Developing Countries: Application to Traditional Knowledge’, in K E Maskus and J H Reichman (eds),

International Public Goods and Transfer of Technology Under a Globalized (CUP, 2005), 337, 349. 199 Ruiz Muller 2018 (supra, n 25). In the context of TK, see also Ruiz Muller 2013 (supra n 154). 200 Ruiz Muller 2018 (supra, n 25), 14. 201 Vogel et al 2017 (supra, n 13), 378 to 379, building on the work of Oldham et al. 202 Ruiz Muller 2018 (supra, n 25), 14. 203 Ruiz Muller 2018 (supra, n 25), 18. 204 There is extensive literature on the application of the concept bounded openness, see for example Vogel et al

2017 (supra, n 13). 205 Ruiz Muller 2018 (supra, n 25), 2, building on Vogel et al 2017 (supra, n 13).

44

where they have unequal capacities. These points are discussed more fully below where

existing international practice in fund disbursement is considered.

ii. A general (biodiversity) fund

The second form of disbursement, which is not based on liability regime, would involve

payment to and from general fund. This fund would likely be utilised to fund specific projects

or programmes based on defined criteria, linked to the CBD objectives and relevant SDGs.

Many international funds provide, at least among others, for project-based funding. The Global

Environment Facility (GEF) of the World Bank, for example, can cover the incremental costs

of projects,206 whilst the ITPGRFA’s Benefit-Sharing Fund primarily provides project-based

grants.207 Project-based funding alone, however, may raise questions of equity when funding

is limited and thus causes competition between applicants which may have unequal

capacities.208 Issues can be exacerbated when financing is loan-based, generating debt for those

seeking to address problems that may not directly relate to their own doing or which efforts

may provide global benefits.209

More comprehensive funding strategies may take a more programmatic approach. Funding, in

this regard, may be of an enabling nature targeted to the very development of strategic

programmes, sometimes mandated under a relevant treaty, such as a national action plan, or

for the effectuation of such a strategic programme. The Global Fund to Fight AIDS,

Tuberculosis and Malaria (GFATM)210 provides an example of a fund that seeks to combine

both strategic financing, for example, for the implementation of national strategic health plans,

and project- or activity-based grants, notably with regard to specific communities, in a single,

national application.211

Applied to the current context, important questions would need to be asked in advance of

establishment of such a fund as to how monies are distributed. An iterative process, drawing

on experience of other funds such as those discussed above would ideally be engaged in to

develop criteria for the disbursement of funds, whether these are disbursed at a project or

programmatic level. Specific selection criteria for funding will depend on the objectives of the

fund, and experience at international level suggests that this is often closely linked to the

206 ‘The Global Environment Facility. Investing in Our Planet’ (The Global Environment Facility)

https://www.thegef.org/, accessed November 2019 207 ‘Benefit-Sharing Fund’ (FAO) http://www.fao.org/plant-treaty/areas-of-work/benefit-sharing-

fund/overview/en/, accessed November 2019. 208 Morgera 2018 (supra, n 42), 65; S Louafi, Reflections on the Resource Allocation Strategy of the Benefit

Sharing Fund (Swiss Federal Office for Agriculture, 2013). 209 See in this regard notably criticism of previous climate funds like the World Banks’ Climate Investment Funds

(CIF) B Wu, ‘Where’s the Money? The Elephant in the Boardroom’ (Huffpost 2013)

https://www.huffpost.com/entry/wheres-the-money_b_3499523, accessed November 2019. 210 ‘The Global Fund’ (The Global Fund) https://www.theglobalfund.org/, accessed November 2019. 211 Modular Framework Handbook (The Global Fund, 2019). Note that the Handbook contains a very

comprehensive list of ‘modules’ that could be funded by the Global Fund, organised under different ‘intervention

packages’ that also include lists of indicators of success.

45

overarching treaty and is sometimes further specified through different priorities, focal areas

or funding windows. These are very much essential for the overall success of the fund.

Illustrative of the above point is the GEF requirement that financial support for projects should

fall within five different focal areas.212 Support will only be provided for the “incremental costs

of projects”: that is, the costs, “associated with transforming a project with national benefits

into one with global environmental benefit”.213 The ‘incremental cost’ criterion is, however,

rather ambiguous and its interpretation politicised, with calculations being ‘endlessly

contentious’.214 A clear lesson to be taken from this is that where the inclusion and

interpretation of such concepts impact on the disbursement, timing and amount of funding, the

potential underlying power asymmetries will have to be given careful consideration when

deciding on the aims and specificities of a multilateral fund. Fund design must also ensure

smaller groups and communities are able to access funds.

Finally, consideration should be given to support for non-monetary benefit-sharing215 activities

such as technology transfer and staff training. Indeed, the environmental funds listed above

also often include opportunities for such technical assistance, sometimes directly linked to

Treaty provisions on capacity building and technology transfer, as in the case of the

ITPGRFA.216 Worth mentioning in this regard is the ‘Readiness and Preparatory Support

Programme’ under the Green Climate Fund (GCF), which, primarily, aims to strengthen the

institutional capacities of National Designated Authorities or direct access entities to

effectively and efficiently engage with and access the GCF funding itself.217 This thus includes

assistance for the development of national arrangements for consideration and facilitation of

funding proposals, for training of staff for project and programme development and support for

stakeholder engagement,218 important examples of non-monetary benefit-sharing.

In regard to the above, any such fund would likely benefit from better understanding of the

interface with non-monetary benefit-sharing such as strengthening research institutions and

advancing conservation activities and conservation science in high biodiversity regions. The

multilateral identification of gaps in the current landscape of international funds and of actual

needs in biodiversity-rich countries could be supported by the global platform for dialogue

212 Biodiversity, climate change, land degradation, international waters, chemicals and waste: GEF Secretariat,

'Gef-7 Replenishment. Programming Directions.' (2018) GEF/R.7/19. 213 ‘Incremental Costs’ (Global Environment Facility 2007) https://www.thegef.org/documents/incremental-

costs, accessed November 2019; also J Gupta, ‘The Global Environment Facility in Its North‐South Context’

(1995) 4 Environmental Politics 19, 25. 214 Z Young, A New Green Order? The World Bank and the Politics of the Global Environment Facility (Pluto

Press 2002), 149. 215 Though see discussion below option 6 and 7 on the false dichotomy between monetary and non-monetary

benefits. 216 E Tsioumani, ‘Beyond Access and Benefit-Sharing: Lessons from the Emergence and Application of the

Principle of Fair and Equitable Benefit-Sharing in Agrobiodiversity Governance’ in Fabien Girard and Christine

Frison (eds), The Commons, Plant Breeding and Agricultural Biotechnologies: Challenges for Food Security and

Agrobiodiversity (Routledge 2018). 217 ‘Readiness Support’ (Green Climate Fund) https://www.greenclimate.fund/gcf101/empowering-

countries/readiness-support, accessed November 2019. See more broadly on the role of national entities in the

GCF system: UNFCCC, 'Governing Instrument for the Green Climate Fund' (2011) FCCC/CP/2011/9/Add.1. 218 GCF Handbook. Decisions, Policies, and Frameworks (2019), 408.

46

discussed in option 6 below. Useful features for the platform can also be derived from the

discussion of the governance of international funds below.

c) Governance, accountability and decision making

Any multilateral benefit-sharing fund would be required to establish a governance system for

decision making in respect of disbursement of funds. Here, existing international practice can

be drawn on, in order to distil important lessons for the present context. With regard to decision-

making on funding applications, existing multilateral funds rely on a central governing board

with representatives. Numbers of members vary between 7 (ITPGRFA’s Benefit-Sharing

Fund) and 32 (Global Environment Facility) and primarily include government representatives

with at least an equal number of representatives from developing and developed countries (see

Annex below). Additionally, the Global Agriculture and Food Security Program’s (GAFSP)

Steering Committee originally also included representatives from the World Bank and

supervising entities (e.g. FAO, IFAD, IFC),219 whilst the Global Fund’s Board of 20 (voting)

members includes seats for major national donors as well as developing countries. But it also

notably includes representation from an NGO from both the developing and developed world,

a representative of someone living with the diseases associated with the fund and the private

sector.220 UNAIDS, the WHO, the World Bank and a Swiss member (since that is where the

Global Fund is incorporated221) have non-voting advisory seats.222

As executive bodies have the final say on funding applications, the power balances that follow

from its structures and decision-making procedures will have to be given careful consideration.

Equal country representation is in this regard not necessarily sufficient, if other factors –

including elements of funding discussed above – are geared to tip the scale in one direction.

This can be illustrated by GEF, whilst despite 56% of representatives from developing

countries or economies in transition and with voting done by consensus, in the past, negotiators

and others actors have expressed that they felt that there was frequently “no alternative but to

agree” with donor countries.223

In contrast to the GEF, the GFATM Board must first try to reach decisions by consensus.224

Where a vote is taken, a weighted two-thirds majority must be reached comprising the group

of donor and private seats, as well as the group consisting of the NGO seats, the developing

country seats and the representative who is a person living with one of the diseases covered by

the Fund.225 Such a model is clearly designed to both “broaden the deliberative process and to

safeguard stakeholder participation.”226 This dedication to broad stakeholder participation

helps to ensure equity in the way in which decisions are made by the Global Fund’s board.227

219 Framework Document for a Global Agriculture and Food Security Program (GAFSP) (World Bank Group,

2009), 34; although these entities are still part of GAFSP they do not have any voting power. 220 ‘Board. Members’ (The Global Fund) https://www.theglobalfund.org/en/board/members/, accessed

November 2019. 221 On the reasons for this, see Klock 2016 (supra, n 189), 160. 222 Sekalala 2017 (supra, n 187) 197. 223 Gupta 1995 (supra, n 213) 20. 224 Sekalala 2017 (supra, n 187) 197. 225 Ibid. 226 Ibid. 227 Ibid.

47

Such multi-sectoral stakeholder participation is further enhanced by the availability of a

partnership forum as well as a Global Online Forum.228 Worth mentioning in this regard is

Gavi, the Vaccine Alliance, whose board includes an equal balance of donor and recipient

countries as well as three intergovernmental organisations – the WHO, UNICEF and the World

Bank – together with representatives of vaccine manufacturers from both the developed and

developing world.229 Other board seats are reserved for the Gates Foundation, as well as

representatives of civil society. Further seats are allocated based on the needs of the

organisation230 and it is notable that Gavi is recognised as one of the most transparent agencies

in the world.231 While Gavi’s Board focuses on wider strategy, it is nevertheless an interesting

institution for its emphasis on representation from a wide array of constituencies as well as

transparency.

The governing board will, for its decision-making, also be likely to be supported by an advisory

and/or technical body. Of particular inspiration can be in this regard the structure provided by

the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), which uses both a

Technical Review Panel (TRP) of independent experts to evaluate the technical merit of

proposals, and a Grant Approvals Committee to make funding recommendations based on the

Panel’s opinion and a proposal’s wider strategic value.232 The Technical Review Panel in

particular has been commended for being able to direct funding in the direction of countries

most in need, without ex ante allocation, whilst flagging capacity concerns (and language

barriers) where relevant and promoting substantial learning, thereby having been held to

potentially provide inspiration for other (incl. environmental) multilateral mechanisms.233

Moreover, the GFATM has also been put forward as an example of largely successful

integration of local, bottom-up knowledge (through Country Coordination Mechanisms) and

independent, technical expertise (through the Technical Review Panel) in decision-

making.234

Questions will need to be raised and answered as to how funds can be accessed, notably who

is able to apply for funding and who decides on the application. In this regard, significant

differences can be seen when comparing institutional structures within existing multilateral or

global funds. With regard to potential applicants, the ITPGRFA’s Benefit-Sharing Fund seems

to position itself on one side of the spectrum, by focusing on direct access for State Parties, or

any legal or natural person, including gene banks and research institutions, farmers and

farmers’ organisations.235 Despite a helpdesk providing assistance for the preparation of

228 Ibid, 208 229 Klock 2016 (supra, n 189), 170. 230 Ibid. 231 Ibid, 174. 232 ‘Technical Review Panel. Overview’ (The Global Fund) https://www.theglobalfund.org/en/technical-review-

panel/, accessed November 2019. 233 G Schmidt-Traub, ‘The Role of the Technical Review Panel of the Global Fund to Fight Hiv/Aids, Tuberculosis

and Malaria: An Analysis of Grant Recommendations’ (2018) 33 Health Policy Plan 335. 234 L Van Kerkhoff and N A Szlezak, ‘The Role of Innovative Global Institutions in Linking Knowledge and

Action’ (2016) 113 PNAS 4603, although the authors also find that some countries have succeeded better than

others in maintaining ‘country ownership’ of the process and outcomes than others. 235 FAO, 'Report of the Third Session of the Governing Body of the International Treaty on Plant Genetic

Resources for Food and Agriculture' (2009) Resolution 3/2009.

48

proposals, concerns have been raised of capture of the process by well-established groups and

the inability of farmers – the primary target group under the Treaty236 – to reach the

international level through complex procedures.237 On the other end of the spectrum is the

Global Fund to Fight AIDS, Tuberculosis and Malaria, where a separate national committee

called a Country Coordination Mechanisms is tasked with the submission of comprehensive

proposals.238 These include representatives from various sectors: multilateral or bilateral

agencies, nongovernmental organisations, academic institutions, faith-based organization, the

private sector and people living with the diseases,239 with this inclusive approach being helped

by the fact that funding is primarily demand- rather than supply-driven. Nonetheless, issues

have occurred when civil society representation did not always reach recommended (40%)

quota,240 or when a heavy presence from donor countries could be felt within the Country

Coordination Mechanisms.241 In response to this, the GFTAM has reviewed its grant

architecture to ensure more by way of country ownership as well as enhanced NGO

involvement.242 This shows the need for an iterative approach to the development of these

funds, which allows to respond to what is learnt in implementation and the benefits of

reflexive and self-critical approach has led to strengthened Country Coordination

Mechanisms with greater sectoral and societal engagement.243

An example of a more hybrid approach is GEF’s Small Grants Programme which has been held

to work fairly well, and which can be directly accessed by community-based organizations and

non-governmental organizations with assistance from a National Coordinator. Although the

scheme follows GEF’s focus on global benefits, it aims to do so through community-based

initiatives and actions.244 There have been examples in which the GEF Small Grants

Programme has been more tightly linked to multilateral processes, such as under the

Minamata Convention. These cases could be studied in more detail, considering that the

GEF is already the funding mechanism for the CBD and the Nagoya Protocol, with a view

to assessing in what ways they could contribute to integration of local, bottom-up

knowledge and independent, technical expertise, as well as greater sectoral and societal

engagement with a view to supporting participatory and iterative learning around DSI,

the CBD objectives and their contributions to the SDGs. Whereas other multilateral

mechanisms have also opted for more hybrid approaches, it follows from the above that equity

236 Article 13.3 ITPGRFA. 237 Tsioumani 2018 (supra, n 216); S Louafi, Reflections on the Resource Allocation Strategy of the Benefit

Sharing Fund (Swiss Federal Office for Agriculture, 2013). 238 The Global Fund to Fight Aids, Tuberculosis and Malaria. The Framework Document (The Global Fund,

2001), 94. 239 ‘Country Coordinating Mechanism. Overview’ (The Global Fund) https://www.theglobalfund.org/en/country-

coordinating-mechanism/, accessed November 2019. See more broadly on stakeholder participation in the context

of another funding mechanisms (GEF) discussed in this section, for example, GEF Council, 'Policy on Stakeholder

Engagement' (2017) SD/PL/01. 240 Country Coordinating Mechanisms. Governance and Civil Society Participation (The Global Fund, 2008), 7. 241 C Clinton, ‘The Global Fund: An Experiment in Global Governance’ (University of Oxford 2014), 319. 242 Sekalala 2017 (supra, n 187) 200 – 201. 243 Ibid. 244 See also table below and, for example, the GCF Accredited Entities under the GCF and the Operational Focal

Points under the GEF.

49

in access opportunities relies upon the abilities of institutions and individuals and the

availability of adequate capacity support.

Overall, it can be concluded that:

The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATAM) provides a

useful starting point for the development of a multilateral/global fund, notably because

of its Country Coordination Mechanisms and Technical Review Panel institutional

structures.

To make it a better fit for the biodiversity context, efforts could primarily be focused

on further integration of local and indigenous knowledge in decision-making

procedures, learning from the experience of the GEF’s Small Grants Programme and

the challenges encountered under the ITPGRFA Benefit-sharing Fund. Active

involvement of those on the ground is necessary to realize the benefit-sharing rationale

‘to share’ (implying agency, rather than of the passive enjoyment of benefits).245

Gavi, with its innovative approach to financing in the form of the IFFIm, together with

its commitment to transparency, may also provide something of exemplar for

development of a multilateral or global fund for biodiversity.

It is also notable that both GFATM and Gavi are public-private partnerships,246

created because, ‘existing international mechanisms plateaued in their impact.’247

While both organisations are not without criticism,248 they nevertheless are considered

to, “create opportunities for consensus-building and resource mobilisation,” through

their use of, “(n)ovel forms of shared decision-making and operations”… “which give

both private and public actors a shared space to structure and build solutions to

problems … that had previously appeared intractable.”249 By extension, public-private

partnerships may perform important ‘regime straddling’ roles and be able to work

within polyglot networks comprised of a “mix of activities, goals and purposes.”250

This is in contrast to traditional intergovernmental organizations, which may often act

as hosts to regime shifting by states and other actors.251 Public-private partnerships

may also bring sectors and actors with very different worldviews together, in an effort

to transform transnational norms.252 The potential of public-private partnerships is

discussed further below.

d) Sites of governance

245 Morgera 2018 (supra, n 42), 57. 246 Sekalala 2017 (supra, n 187), 196. 247 Klock 2016 (supra, n 189), 175 248 See, for example discussion in Gostin 2014 (supra n 190), Chapter 5. 249 Klock 2016 (supra, n 189), 175 250 M Chon, 'PPPs in global IP (public private partnerships in global intellectual property' in Graeme B. Dinwoodie

(ed) Methods and Perspectives in Intellectual Property (Edward Elgar Publishing, 2013), Chapter 11, 283 251 L R Helfer, ‘Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property

Lawmaking’ (2004) 29 Yale Journal of International Law

available at https://digitalcommons.law.yale.edu/yjil/vol29/iss1/2, accessed December 2019. 252 Chon 2013 (supra, n 250), 283. Please note there is a vast literature on public-private partnerships to achieve

sustainable development. See, for example, Philipp Pattberg and others (eds), Public–Private Partnerships for

Sustainable Development: Emergence, Influence and Legitimacy (Edward Elgar, 2012)

50

(At least) three potential sites of governance may be identified in respect of the establishment

of a multilateral fund.

iii. Nagoya Protocol

The first would involve the establishment of a global multilateral benefit-sharing mechanism

pursuant to Article 10 of the Nagoya Protocol. Indeed, there has been extensive discussion in

the literature on the potentially useful utility of Article 10 to resolve the DSI quandary,253 which

relates to the fact that, “some third party commercial uses of genetic information from publicly

accessible databases can be analogised to a transboundary situation or a situation where it is

not feasible to get consent.”254 In essence, a transboundary situation may eventuate when a

“gene, a metabolite, a design from biomimicry … is diffused over species and the species, over

jurisdictions.”255 It could be established as a compensatory liability regime, a broader general

fund or a hybrid. There are significant challenges, however, confronting the Nagoya Protocol

(including continued diverge of views on Article 10, more limited membership than the CBD),

so it may not be preferable to establish such a fund under its auspices.

iv. CBD

An alternative approach would be to create a biodiversity fund under the CBD with

contributions from different sources, including for the use of various components of

biodiversity. While aiming to address the issue of monetary benefit-sharing for DSI under the

Nagoya Protocol, its scope would be broader and would be largely structured as a broader

general fund, though that is not to say that compensatory approaches could not be included as

a hybrid. This would arguably go beyond the scope of Article 10.256 Several provisions under

the CBD could contribute to provide the legal basis of the establishment of such a fund and

contribute to a reflection by CBD Parties on more effective and integrated implementation of

its three objectives.

Both the creation of a biodiversity fund under the CBD and a DSI global multilateral benefit-

sharing mechanism would involve the creation of additional institutional machinery, with

associated costs attached. Furthermore, for the proposed CBD biodiversity fund, concern may

arise that it would not directly address the DSI issue. Instead, by accommodating different

negotiating positions, it could actually result in a lack of legal certainty as well as potentially

‘waste’ institutional resources and risk of competition with other international biodiversity

funding sources.

v. Global Fund for Biodiversity as a public-private partnership

A final approach would be to build on the model of the Global Fund to Fight AIDS,

Tuberculosis and Malaria (GFATM) discussed above and construct a funding body outside of

the existing ABS space. This could be called the Global Fund for Biodiversity – GFBio. The

rationale for the creation of such a fund outside of the existing ABS space is similar to that of

253 See also E Morgera, ‘What to expect on benefit-sharing from the upcoming 2018 UN Biodiversity Conference

(Part II: Nagoya Protocol)’ (BeneLex Project, 2018) https://benelexblog.wordpress.com/tag/nagoya-protocol/,

accessed December 2019. 254 Bagley 2016 (supra, n 131), 12. 255 Vogel et al. 2017 (supra, n 13), 383. 256 Though this is of course somewhat of a contested point.

51

the GFATM; that “existing international mechanisms plateaued in their impact.”257 The

proposed fund could be financed by certain of the mechanisms discussed above, but could also

ensure more by way of financial certainty by drawing funding from more innovative financial

mechanisms such as bonds underwritten by supportive governments. As noted above,

inspiration could be drawn from Gavi’s International Finance Facility for Immunisation under

which bond holders are paid back over the longer term by donors. It is anticipated that

governments hosting industries particularly reliant on DSI would act as donor countries in the

first instances. A bond issue such as that proposed above could utilise the World Bank or the

FAO258 as a treasury manager and would fit within the growing discourse promoting ‘ethical

investing.’

The proposed GFBio could be structured as a public-private partnership, thereby allowing for

flexibility in its construction, as well as speed in its establishment. The GFTAM was, for

example, established over a six-month period.259 Relevant intergovernmental organizations

could be invited to participate as board members. Funding would be disbursed in accordance

with priorities agreed by a broad range of stakeholders and thereby echo the GFTAM’s

emphasis on partnership and bottom-up approaches. The GFBio could also incorporate

elements of option 6 below in terms of acting as a forum for dialogue, oversight and priority

setting for DSI and could give a wide array of constituencies a voice in its operation and

governance. This may help to move us away from some of the more ‘silo-ed’ positions which

currently surround DSI and potentially promote the underpinning logic of benefit-sharing as

an “iterative process, rather than a one-off exercise, of good-faith engagement among different

actors that lays the foundation for a partnership among them.”260 Accordingly, while the GFBio

may appear at first site to offer opportunities for monetary benefit-sharing without confronting

‘head on’ the issue of DSI261 under the CBD or the Nagoya Protocol, it could act as a forum

for dialogue and priority setting in this regard. This would potentially help to address a “core

challenge for new forms of cooperation” which is their ability to take, “into account of external

stakeholder interests. Coalitions of the willing may be created. Yet, these may also affect

(directly or indirectly) outsider state or private actors.”262

vi. Fragmentation and the CBD

While the public-private partnership model clearly has advantages, it must also be recognised

that such a model creates significant risks of “fragmentation … of state-centric legal

frameworks and a corresponding shrinkage of public goods” provision.263 By extension,

countries with limited resources may find it difficult to be active across an ever-increasing

range of international structures.264 In this regard, establishment of a GFBio would raise

257 Klock 2016 (supra, n 189), 175. 258 ‘Benefit-Sharing Fund’ (FAO) <http://www.fao.org/plant-treaty/areas-of-work/benefit-sharingfund/

overview/en/>, accessed November 2019. 259 See discussion in Sekalala 2017 (supra, n 187), Chapter 7. 260 See Morgera 2018 (supra, n 42). 261 See generally ibid. 262 J Pauwelyn, R A Wessel and J Wouters, ‘When Structures Become Shackles: Stagnation and Dynamics in

International Lawmaking’ (2014) 25 (3) European Journal of International Law 733, 752 and 738. 263 Chon 2013 (supra, n 250), 296. 264 Ibid.

52

significant concerns with respect to the potential dilution of authority of the CBD on the

international sphere. At a time when biodiversity most needs protecting, erosion of the

influence of the CBD appears a misstep. Indeed, the CBD offers the treaty objectives under

which such a fund should operate.

Accordingly, the establishment of a fund under the CBD offers significant advantages from an

international law perspective, though the lessons learned above with respect to the importance

of facilitating dialogue, oversight and involvement of a range of constituencies should be borne

in mind when creating such a fund such as:

the development of institutional structures such as the Country Coordination

Mechanisms and Technical Review Panel for the operation of the Global Fund to Fight

AIDS, Tuberculosis and Malaria (GFATAM)

more innovative financing mechanisms such as a bond issue, drawing on the

experiences of Gavi, the Vaccine Alliance to ensure short-term financial sustainability

that would also nurture trust among various actors;

governance with relevant ‘constituencies’ such as database managers, developing

countries, the scientific community and indigenous communities represented in its

decision-making processes, drawing inspiration from the GFATM .

The key idea here would be to give both “private and public actors a shared space to

structure and build solutions to problems … that had previously appeared

intractable.”265 Dialogue with a range of affected stakeholders is therefore an important

underpinning principle and indeed, we explore this option below (option 7) where we

propose a so-called hybrid approach whereby a multilateral fund established under the CBD

is accompanied by a multilateral platform for dialogue, learning, oversight and priority-

setting.

265 Klock 2016 (supra, n 189), 175.

53

Option 6: A multilateral platform for benefit-sharing

Whereas the analyses of options 5 have focused primarily on a multilateral fund as a monetary

benefit-sharing option, this option explores a more principled approach to ensure that available

resources, regardless of the way they are generated, are targeted in such a way to ensure fairness

and equity in relation to benefit-sharing.266 Such a principled approach is mainly concerned

with establishing a multilateral platform for dialogue, oversight and priority-setting around DSI

to support global partnerships on scientific cooperation for conservation and sustainable use.

The platform could allow approaching the DSI issue ‘from the side’, moving beyond the

dichotomy inherent in the perception of monetary versus non-monetary benefits, definitions

and the subject-matter scope of the CBD, in order to concentrate on dealing with the actual

barriers to the realization of equity and fairness in benefit-sharing. In this regard, this option

builds upon and implements existing obligations and opportunities, notably on information-

sharing, capacity-building, technology transfer and scientific cooperation as forms of benefit-

sharing. The creation of a multilateral platform is a recommended option, that is both

compatible with a multilateral fund (option 5 above) and can respond to the shortcomings

identified in previous options if it is implemented as part of a hybrid solution, discussed as

option 7 below.

a) Beyond monetary and non-monetary benefits

A platform for coordination of efforts and multilateral cooperation would allow us to beyond

narrow debates on the nature and types of benefits that can and should be shared. Such a

platform would notably also allow us to move beyond the traditional - and in our view false –

distinctions typically made between monetary and non-monetary benefits. In this regard, an

argument that is often brought against the formalisation of benefit-sharing arrangements

regarding use of DSI, and of monetary benefits in particular, is that publication of sequences

in open access databases already represents a significant form of non-monetary benefit-sharing

as it allows anyone, including researchers in provider countries and the Global South, to use

the information.267 This argument, however persistent, does not take into account the limited

capacity of different countries and different users to access and make use of the information

contained in databases.268 Similarly, power imbalances may also impact on the way actors can

control their data once it has been publicly shared, or on the way research collaborations are

structured and conducted. Nonetheless, many countries in the Global South, such as Brazil,

South Africa and Malaysia, are both user and provider and are likely to benefit from open

access.

As the above illustrates, an emphasis on the difference between monetary and non-monetary

benefits reveals a false dichotomy, which lies in the fact that non-monetary benefits ultimately

bear economic costs,269 and rely on financial investment in support of capacity building to level

266 This analysis primarily draws upon Morgera 2018 (supra, n 42). 267 CBS/SBSTTA/22/Inf/2, 21. 268 Ibid, 20. Note, however, that the recent CBD study on traceability does find that users of information in the

main databases (INSDC databases) are distributed fairly homogenously over all countries of the world: Rohden

et al 2019 (supra, n 46), 27. 269 Morgera 2018 (supra, n 42), 54.

54

the playing field and realise their full potential. In this regard, a multilateral platform could

focus on overcoming the actual barriers to the realization of equity and fairness in benefit-

sharing and could be based on a dialogue with expected beneficiaries, and on the identification

of integrated responses.

Our proposed multilateral platform is underpinned by a concern for cooperation, as well as

facilitating and brokering scientific cooperation and capacity building. The proposed platform

is an attempt to provide space for dialogue between the multiplicities of actors involved in the

use of DSI, with a view to producing a more effective response to their needs. The proposed

multilateral platform could also facilitate the co-production of ‘solutions’ to DSI, with such co-

produced solutions encompassing the views and needs of the range of communities involved.

In this sense, we foresee that such a platform could allow for inter-institutional, inter-sectoral

and cross-scalar learning.

b) Taking inspiration from the governance of the GLIS: tackling the issue ‘from the

side’

An example of a platform for multilateral cooperation can be found under the ITPGRFA, where

the Global Information System (GLIS) has arguably been devised to address specific barriers

to fair and equitable benefit-sharing in the form of information-sharing not just through the

creation of an online database but the inter-linked development of a multilateral platform for

targeted dialogue and iterative learning. The GLIS thus aims to facilitate fair and equitable

benefit-sharing, by increasing interoperability of systems, by creating a mechanism at the

multilateral level to undertake a series of inter-related tasks that identify and address

shortcomings in bilateral relations, namely: assessing progress and monitoring effectiveness of

enhanced and coordinated information-sharing opportunities; providing institutional support to

broker and oversee scientific cooperation and capacity-building; and identifying any gaps or

issues that could proactively be addressed at international level.270

A positive aspect of the approach is the fact that it tackles the issue of DSI “from the side,

rather than head on”.271 It does not necessarily require agreement on a definition or on DSI’s

inclusion in the scope of the CBD or the Nagoya Protocol. Instead, it provides a combined

approach to strategic implementation of existing obligations and opportunities, notably on

information-sharing, capacity-building, technology transfer, scientific cooperation as forms of

benefit-sharing. It may also explore and systemise opportunities among existing infrastructures

and practices, such as open-access databases and their approaches to attach use conditions to

DSI.272

Another interesting aspect of the GLIS is its reliance on existing information systems273 with a

view to minimising the impact on current infrastructures and procedures, and focusing on

270 Ibid, 58. Article 17 ITPGRFA; GLIS terms of reference. 271 Ibid, 75. 272 Ibid, 74. These include conditions of use notices, click through agreements, open source MTAs, and user

agreements, see also above Option 1 and Laird and Wynberg 2018 (supra, n 5) 36-39. 273 Article 17(1) ITPGRFA.

55

improving interoperability.274 One means it employs to do so,275 is adding a ‘digital object

identifier’ (DOI) to identify a resource. DOIs are designed to coexist with other identifiers that

often aim to serve particular communities and the achievement of specific objectives. The DOIs

are hence intended to be used for “all purposes that are beyond the intended scope of existing

identifiers, such as information sharing across different information systems and different

communities”.276

The GLIS can also provide a helpful example for the creation of a clearing-house mechanism

under the BBNJ instrument.277 As a web-based entry point to information and knowledge,

accessible via < https://ssl.fao.org/glis/>, it is geared both to the strengthening of capacity for

the conservation, management and utilisation of resources and the sharing of benefits, and pays

special attention to the needs of developing countries.278 In doing so, it provides more than an

online repository of information, which is the primary function of the clearing-houses under

the CBD and the Nagoya Protocol. By contrast, the GLIS Programme of Work foresees a

comprehensive, phased approach, covering not only the creation of a web-based platform, but

also aiming to facilitate access to sources and associated information. It also aims to promote

and facilitate interoperability and transparency on rights and obligations of users, to enhance

opportunities for communication and international and multidisciplinary collaboration, to

provide for capacity development and technology transfer for the conservation, management

and use of resources, and to create a mechanism to assess its own progress and monitor

effectiveness.279

It is notable, however, that GLIS is still in the very early stages of development, having mainly

focused on assigning DOIs across organisations,280 and it has not been free from controversy.281

Nonetheless, GLIS provides an important example of conceiving of fair and equitable benefit-

sharing as a governance process that needs inter-institutional, inter-sectoral and cross-scalar

learning. In particular, where GLIS focuses on opportunities and synergies within and between

existing systems, there lies potential for an approach that is developed from direct dialogue

with the scientific community, thus minimising risks of negative and unforeseen impacts on

scientific cooperation and innovation and maximising opportunities for biodiversity

conservation and its contributions to multiple SDGs. Such an approach can contribute to build

trust across the current divides in the DSI debate, by demonstrating sustained commitment to

understanding the actual causes of inequity in a dialogue with affected communities and to co-

274 The Governing Body to the ITPGRFA, 'The Vision and the Programme of Work of the Global Information

System' (2015) IT/GB-6/15/Res 3, Annex I, par 3. 275 See also above option 3. 276 ‘FAQS - the GLIS Portal and Digital Object Identifiers’ http://www.fao.org/plant-treaty/areas-of-

work/global-information-system/faq/en/, accessed October 2019. 277 Morgera 2018 (supra, n 42). 278 Article 13(2) and Article 17 ITPGRFA and ITPGRFA Res 3/2015, Annex 1, par 6; also, Morgera 2018 (supra,

n 42), 76. See on how these articles relate to GIS and the other workings of the multilateral system also: C Ker et

al, ‘Building a Global Information System in Support of the International Treaty on Plant Genetic Resources for

Food and Agriculture’ in Halewood et al (eds), Crop Genetic Resources as a Global Commons: Challenges in

International Governance and Law (Routledge 2013). 279 ITPGRFA Res 3/2015, 4-6 with detailed indicators on how these broader objectives can be achieved. 280 A Alercia et al, Digital Object Identifiers for Food Crops. Descriptors and Guidelines of the Global

Information System (FAO, 2018). 281 Morgera 2018 (supra, n 42), 75 briefly on issues with regard to the DivSeek initiative.

56

develop in a transparent and multilateral setting problems that usually arise, and may remain

hidden or underestimated in their cumulative/systemic impacts, at the bilateral level.

Moreover, inspiration to further sharpen and develop the approach may be drawn from other

international processes, to ascertain how their terms and conditions can support the aims of the

multilateral platform.282 The proposed approach would not be completely novel under the

CBD, with the Sustainable Ocean Initiative (SOI) Global Dialogue with Regional Seas

Organizations and Regional Fisheries Bodies on Accelerating Progress towards the Aichi

Biodiversity Targets able to provide a precedent in this regard. SOI has provided a regular

process to share experiences and identify opportunities to enhance collaboration across sectors

towards internationally agreed goals. It has further allowed for discussions on the need for

specific tools, guidelines or other initiatives with a view to further strengthening opportunities

for collaboration.283

Facilitating opportunities for interactions to promote learning, including through deliberation

by multiple stakeholders,284 is recognized increasingly within international law processes as a

fundamental imperative in situations where a range of actors, and indeed regimes, are

stakeholders to a particular issue. Rather than attempt to resolve issues though, for example, an

emphasis on strict legal hierarchies, deliberative strategies designed to foster learning and

information sharing,285 should be brought to the fore.286 Our proposed multilateral platform

very much fits within such an approach.

c) Facilitating and brokering scientific cooperation and capacity-building

The multilateral platform can provide an opportunity to learn on an ongoing basis how benefit-

sharing approaches to DSI can work or not for scientists, as well as the implications for

biodiversity conservation and sustainable use. On that basis, the platform could proactively

identify opportunities to facilitate and broker, and possibly also oversee and identify gaps or

issues in, an otherwise ad hoc flow of information-sharing, scientific cooperation and capacity-

building activities. A more institutionalized approach could respond to the needs of those

benefitting from information-sharing, provide oversight of the distribution of benefits across

different regions, and contribute to a more systematic encouragement of virtuous circles

through capacity building.

A multilateral platform could also support iterative partnership-building around enhancing the

implementation of CBD and other relevant international instruments such as the proposed

BBNJ instrument. The clearinghouse mechanism already proposed under the current BBNJ

negotiations could, for instance, be envisaged as not just an online repository of information,

282 Note that under Regulation (EU) No 511/2014 (Article 7) research funding is an entry point for monitoring

compliance. 283 ‘Sustainable Ocean Initiative’ (CBD) https://www.cbd.int/soi/, accessed December 2019. 284 M A Young., ‘Fragmentation or interaction: the WTO, fisheries subsidies, and international law’ (2009) 8 (4)

World Trade Review 477, 479. Though see S Oberthür, ‘Interplay Management: Enhancing Environmental Policy

Integration Among International Institutions’ (2009) 9 International Environmental Agreements: Politics, Law

and Economics 371, 382. 285 See generally Young 2009, ibid. 286 See also discussion in Morgera, Switzer and Tsioumani 2018 (supra, n 38).

57

but also a multi-stakeholder process to support a concerted and iterative dialogue to identify

and respond to needs and priorities of beneficiaries, and international institutional support for

setting priorities, brokering scientific cooperation, capacity-building and technology-transfer

opportunities.287 This could also support the identification of users that could become benefit-

sharing trend-setters in their sector (as developers and implementers of best practices in fair

and equitable benefit-sharing), and assess the financial viability of both monetary and non-

monetary benefit-sharing, the challenges in linking monetary benefits to intellectual property

rights as well as the delivery of monetary and non-monetary benefits.288

A principled multilateral approach can also address questions of fairness and equity from a

human rights perspective,289 in order to balance competing rights and interests, avoid

discrimination, and respond to the needs of the vulnerable, while preventing negative

environmental and socio-economic consequences of scientific research. This would be

particularly interesting to align with recent international clarifications of the inter-dependence

of biodiversity and basic human rights (discussed under the hybrid option 7),290 and the need

to interpret and implement the SDGs in accordance with human rights law.291

As discussed in the previous sections, the multilateral platform could also respond to the need

for the international community to understand to the different communities of practices

involved in the use of DSI, thereby more effectively responding to the needs of researchers and

the conservation community through co-development of solutions. The platform would also

assess on an ongoing basis the financial viability and functionality of the system, working

collaboratively with database operators and researchers – both in the Global North and the

Global South, with a view to adapting the system in light of changing scientific practices and

the different economics underpinning particular sectors. The platform could also allow

discussion of any unintended consequences on fairness and equity, including in the use of

various funding and governance options, or the use of copyright-like systems.

d) In conclusion: a multilateral multifunctional platform on DSI

It follows from the above that the adoption of a multilateral approach through a platform for

cooperation (including dialogue, learning, oversight and priority-setting) as recommended by

this study results from a careful combination of:

A clearinghouse mechanism, as a web-based entry point to information and

knowledge;

A forum for dialogue to enhance collaboration across sectors and stakeholders to

contribute to the achievement of the CBD objectives and the SDGs, thereby

o promoting further information sharing (feeding back into the clearinghouse),

deliberation and mutual learning;

287 Morgera 2018 (supra, n 42) 76. 288 E Tsioumani, ‘Beyond Access and Benefit-Sharing: Lessons from the Law and Governance of Agricultural

Biodiversity’ BENELEX Working Paper n 9 (SSRN, 2016), at 28-29. 289 Morgera 2018 (supra, n 42) based on Special Rapporteur in the field of cultural rights (UNHRC), 'The Right

to Enjoy the Benefits of Scientific Progress and Its Applications' (2012) A/HRC/20/26, par 65-69. 290 A/HRC/34/49. 291 A/HRC/RES/37/24 & A/HRC/RES/37/25.

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o providing international institutional support for facilitating and brokering

scientific cooperation opportunities;

o identifying information-sharing, technology-transfer and regulatory and

institutional capacity-building needs and available assistance; and

o building, and assessing the effects of, partnerships, including public-private

partnerships – on the basis of information available on the clearinghouse and

multi-stakeholder dialogue;

A multilateral and multi-stakeholder mechanism to identify and assess obstacles, and

to propose enhancements, to the interoperability of existing systems (arising from the

dialogue with database managers, researchers, users, and feeding into the

clearinghouse); and

A multilateral and multi-stakeholder mechanism to increase transparency about and

assess the distribution of benefits across regions, as well as to discuss good practices

and lessons learnt in ensuring fairness and equity in benefit-sharing (arising from the

dialogue and feeding into the clearinghouse, and incrementally shaping funding and

governance of the platform as a whole).

It is recognised that these and other objectives are unlikely to all be achieved at the same time

and that it will be necessary to set priorities, through a deliberative approach. In this regard,

the multilateral platform could also draw on some of the insights garnered from our analysis of

multilateral funds (option 5 above and the Annex below), notably the emphasis on learning and

building consensus among private as well as public actors through “a shared space to structure

and build solutions to problems.”292 A similar, inclusive and potentially transformative

approach should be taken to the operationalisation of the platform, the allocation of funds, and

continuous reflection on the effectiveness and equity implications of the platform’s workings.

It is noted, however, that more detailed recommendations with regard to the operation,

priorities and governance of the multilateral platform would benefit from further study in

consultations with experts from different disciplines and stakeholders.

292 Klock 2016 (supra, n 189), 175.

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Option 7: Hybrid approach

In this option, which we term the hybrid approach, we combine the multilateral platform for

dialogue, learning, oversight and priority-setting for DSI envisaged in option 6 above, with the

multilateral fund for distribution of benefits set out in option 5. We also revisit a number of our

other options (notably option 4) with a view to proposing improved processes for dealing with

DSI.

A hybrid approach is the most strongly recommended option, because it can combine the

advantages of numerous of the previous options and respond to their individual shortcomings.

It can provide a carefully calibrated approach that can show how it responds to the various

demands expressed by various CBD stakeholders (developed and developing States, the

scientific community, the conservation community). It distinguishes itself from the “shopping

lists” approach, where the international community, unable to find consensus, would identify

a variety of options that are disconnected from each other and risk spreading resources too thin

in trying to pursue them all without clear joined-up thinking. Instead, the hybrid approach

proposed here is based on a reasoned combination of various proposals, structured into a logical

sequence so that the demonstration of how the international community is carefully responding

to the various concerns that have been identified from different sides of the DSI can contribute

(in itself) to pave the way for building trust and political willingness to engage with this

proposal.

a) An overview

The proposed hybrid option combines:

The multilateral platform for dialogue, learning, oversight and priority-setting

(option 6 above). This would focus on:

o Collaboratively identifying of integrated responses to capacity and operational

needs;

o Identifying and co-developing funding mechanisms for monetary benefit

sharing (see below), taking into account the range of needs of relevant actors,

including safeguarding ‘open science’;

o Co-developing criteria for disbursement of funds by a range of stakeholders,

so that benefit-sharing effectively contributes to the holistic realization of the

CBD objectives and relevant SDGs;

o Contributing to governance structures to ensure equity;

o Creating opportunities for learning and iterative design to make sure that the

fund really responds to evolving beneficiaries’ needs and evolving scientific

practices;

o Convening dialogues with stakeholders to stay abreast of the implications of

scientific and technological developments for benefit-sharing and the fund.

A multilateral fund (option 5 above) to ensure financial viability. This could have

multiple approaches, co-developed in phases thanks to the learning approach supported

by the multilateral multifunctional platform (above). This in turn could allow to fit with

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the different economics of different sectors and (sub)sectors, which could draw both

from payments arising from:

o The development of the copyright-like sui generis approach via the creation

of a multilateralised digital domaine public payant to ensure sustainable

financing

o A bond system to ensure financial sustainability in the interim.

The combination of the multilateral multifunctional platform and the multilateral fund could

benefit from the governance approaches of the ITPGRFA GLIS and the GFTAM to integrating

expertise from the bottom up and support the agency of beneficiaries (rather than their passive

enjoyment of benefits) – beneficiaries’ agency is in effect an essential, often overlooked,

element of fairness and equity in benefit-sharing.293 The platform would need to make

specific efforts to ensure the integration of local and indigenous knowledge in decision-making

procedures, as well as scientists from different geographies and capacities, database managers,

experts from different sectors. In this regard, the hybrid approach would build upon some of

the lessons discussed above in respect of the operation of multilateral funds (option 5 above),

with a view to ensuring transparency and genuine partnership-building. It would thereby

include an emphasis on equity in terms of building capacity, as well as the integration of local

expertise. It would also be underpinned by concerns for the promotion of substantive and

continuous learning (across different disciplines necessary to tackle the DSI issues from

different perspectives and a variety of beneficiaries) and take an inclusive and representative

approach to developing guiding principles for both the accrual of funds as well as fund

disbursement.

To those ends, the platform will start with a participatory exercise of peer-learning and peer-

review of the relationship between overall costs and benefits for providers and users, and also

consider concerns for conservation, equity, public health, and open science underpinning the

current approach, as well as of the benefits and costs that are likely to result from moving to a

system of multilateral benefit-sharing. This will be the first step of an iterative process of

participatory evaluation and due diligence that will set a paradigm-shift from the current,

simplistic and predominantly bilateral approach to ABS under the CBD.

b) Opearationalizing the digital domaine public payant as part of the platform

In terms of the establishment of a multilateral fund to accompany the multilateral

multifunctional platform described above, the establishment of a mechanism we term the

‘digital domaine public payant’ (preliminarily discussed above (option 4)), would focus on

generalized benefit-sharing.294

293 Notably in connection with the co-production of knowledge and everyone’s international human right to benefit

from scientific advancements (Universal Declaration of Human Rights Article 27(1); International Covenant on

Economic, Social and Cultural Rights, Article 15): E Morgera, "The Need for an International Legal Concept of

Fair and Equitable Benefit-sharing" (2016) 27:2 European Journal of International Law 353-383, and E Morgera,

"Fair and Equitable Benefit-sharing at the Crossroads of the Human Right to Science and International

Biodiversity Law" (2015) 4 Laws 803-831. 294 Such an approach would also sidestep the fact that certain jurisdictions have denied copyright protection to

hybrid gene sequences - e.g. Delhi High Court in Emergent Genetics India Pvt. Ltd. v. Shailendra Shivam and

Ors (as noted in Welch 2017 (supra, n 18), 23). See also Ruiz Muller 2013 (supra n 154).

61

The operationalisation of the digital domaine public payant would require a determination to

be made in respect of three issues: how and when would payment be made: what sort of

mechanism would payment be made to; and how would funds be disbursed. We deal with each

in turn.

i) How and when would payment be made?

Payment for the digital domaine public payant could be constructed in (at least three) potential

ways. The first would involve payment upon access to DSI, the second would involve payment

upon use, while the third would be based upon payment for use but operationalised through the

blockchain-associated feature of smart contracts.

Payment upon access to DSI would involve constructing a regime somewhat contrary to the

domaine public payant within the cultural sector – whereby payment is generally upon use. In

the case of those accessing DSI, instead, paying a fixed but potentially tiered fee upon access

to DSI through publicly accessible databases would allow to take into account different

categories of users. Payment upon access would ameliorate the need for track and tracing and

address some of the issues of valuation of monetary benefits outlined above. Payments would

be made into a central, multilateral fund and distributed in accordance with the objectives of

the CBD (see also option 5 above and option 2 above).

In order to operationalise a regime of payment upon access, further study and consultation with

all relevant stakeholders including database holders, scientists and conservationists, indigenous

people and local communities would be required, to better understand the impacts of specific

options in practice. Whilst more detailed recommendations are, therefore, beyond the scope of

this study, it is our opinion that potential operationalization of the digital domaine public

payant through the application of a fee applied to public database access, as suggested above,

would only be feasible if encompassed as part of the hybrid approach outlined here. In essence,

the creation of a multilateral platform for dialogue, learning, oversight and priority-setting

envisaged as part of what we term the hybrid option would be underpinned by the principle of

collaboration with, for example, database operators and researchers, with significant

representation of those from the Global South. Accordingly, both normatively, and

operationally, the digital domaine public payant, if instituted through payment upon access to

DSI, is to be differentiated from a stand-alone charge for database access that does not come

with an institutional set-up that addresses, among other things, the need to safeguard the norm

of open science and equity. The distinction here stems from the fact that a stand-alone charge

for database access without the type of engaged conversations with all potential stakeholders

we foresee under the hybrid approach runs the risk of not taking the norm of open science into

account fully in its implementation. Such dialogue would by extension be required in order to

overcome some of the practical issues previously discussed (option 5) with the

operationalisation of a subscription or access fee.

An alternative to payment upon access would be payment upon use. While difficulties abound

with the operationalisation of a system of payment upon use due to the issues with tracking and

tracing discussed previously, inspiration could be drawn from the Pandemic Influenza

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Preparedness Framework’s Partnership contribution which, as noted above (option 5), is paid

by manufacturers of influenza vaccine, as well as diagnostic and pharmaceutical manufacturers

who use the WHO Global Influenza Surveillance and Response System (GISRS). This is

operationalised via a questionnaire sent by the WHO every year to potential contributors, with

the funds then allocated to capacity building, pandemic response and maintenance of the PIP

Framework.295 A similar system could be devised for companies making use of, for example,

the INSDC, with payment, set at a fixed percentage of turnover or gross profit, made

compulsory – as opposed to voluntary - for certain companies using DSI and with a turnover

above a certain threshold. There would hence be no need to track and trace benefits to use,

since any payment would be a fixed fee tied to use of DSI in a broader sense.

The compulsory nature of the system of payment upon use explored above would overcome

the problems with a voluntary scheme discussed above (option 5) and targeting payment at

companies with a turnover above a certain amount would avoid equity issues associated with

payment upon access which could potentially have a detrimental impact upon researchers and

companies from the Global South. Payment upon use could potentially require close

cooperation with databases to ensure that an accurate list of users is compiled although other

mechanisms could potentially be devised here. The operationalisation of a system for payment

upon use would also require close cooperation with Parties in which each applicable company

is domiciled as the compulsory nature of any such fee means that it would likely require to be

imposed at national level before being transferred into a multilateral fund to be disbursed in

accordance with the objectives of the CBD. Accordingly, as with payment upon access,

operationalisation of a system based upon use would require to be situated as part of a

multilateral platform (discussed in option 6) for dialogue, learning, oversight and priority-

setting underpinned by the principle of collaboration with, for example, all interested and

affected stakeholders. Such a platform could potentially also arrive at a process for compulsory

payment direct to a multilateral fund, as opposed to being imposed domestically before being

disbursed to a multilateral fund. This would have the positive effect of not interfering with

already existing domestic schemes such as Brazil’s 1% levy upon use (option 5 above), though

it could result in a double burden of payment for certain companies. This would require careful

consideration, as would the fact that any such charge, as noted above, if implemented nationally

(depending upon what is agreed), could cause concrete problems for implementation and result

in patchy compliance across jurisdictions. Similar issues with the implementation of a

biodiversity tax were also raised above (option 5).

It should be noted that one significant disadvantage of either system is of course the likely non-

cooperation of the United States in any such system, though this is an issue which underpins

any attempt to ‘resolve’ the issue of DSI multilaterally. However, the phased, iterative

approach which underpins the hybrid option discussed here with a multilateral fund being tied

295 ‘Influenza – PIP Partnership Contribution’ (WHO, n.d.)

https://www.who.int/influenza/pip/partnership_contribution/en/, accessed December 2019. See also Rourke et al.

(supra, n 184).

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to a learning platform may be of interest to a range of actors in the US, thereby potentially

helping to bring about a transformation in worldviews (see discussion below at (d)).

Of course, some might suggest that an alternative to, or a complement to the above, could be

operationalisation of the digital domaine public payant through the blockchain-associated

feature of smart contracts (option 3 above). Nonetheless, the disadvantages of the use of

blockchain need to be reiterated here (energy footprint, requirement for users to have sufficient

computer power to participate, the potential incompatibility with existing databases such as

INDSC, and the issue that data can often still be accessed outside of the blockchain). Rather

than including blockchain in a hybrid approach, we see merit in instead using the multilateral

platform discussed above (option 6) to identify in a collaborative manner with database

operators and researchers in the Global North and the Global South ways to improve the

functioning and inter-operability of existing structures. This could, for example, involve greater

operationalisation and use of clickwrap or clickthrough agreements that are sparsely used by

some databases. Accordingly, regardless of how the digital domaine public payant is instituted,

the multilateral platform discussed above (option 6) is a vital element to its operationalisation

going forward.

It is to be noted that there may well be other mechanisms to ensure payment under the digitial

domaine public payant with the multilateral platform discussed above being central to the

process of deciding upon how best such payment can be secured. The platform would be based

on a process of dialogue to ensure that a scheme designed to promote equity via monetary

benefit-sharing does not result in inequity through an adverse impact on, for example,

researchers from the Global South. In addition, the choice of the appropriate method would be

based on learning across sectors such as those from the cultural heritage arena to really get a

sense of the various options available and their implications for the CBD objectives. As

discussed previously, the multilateral platform could draw on some of the insights garnered

from our analysis of multilateral funds (option 5 above and the Annex below), including the

emphasis on the creation of opportunities for consensus building, as well as offering both

private as well as public actors “a shared space to structure and build solutions to problems.”296

The relationship between the digital domaine public payant and the platform is thus crucial.

The platform ensures that all potential impacts of any payment upon open science are

considered and dealt with before implementation of such a charge. The platform is therefore

vital as a practical and structured mechanism to ensure that any potential negative impacts of

the payment on open science are avoided by engaging in direct dialogue with scientists. In

essence, the platform will help to calibrate any potential implementation of the digital domaine

public payant in response to the actual needs of scientists by including them as stakeholders in

the conversations around responding to DSI. The platform would also support and document

learning about the use and impacts of digital domaine public payant so that the latter can be

gradually improved in light of experience.

Finally, it should be underscored that the digital domaine public payant is only one potential

way to secure funding for the hybrid approach. To that end, dialogue under the platform can

296 Klock 2016 (supra, n 189), 175.

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tease out more clearly the risks and benefits of different options for accruing monetary benefits,

though, clearly, more studies would be required here. Without it (or a similar mechanism to

generate monetary benefits), significant risks exist to equity, legal certainty and innovation if,

for example, more restrictive national regimes on DSI are implemented.

It also needs to be noted that the iterative, horizontal approach to mutual learning envisaged

under the platform could well reject the feasibility of the digital domaine public payant at the

current time, in which case the other options (including innovative financing mechanisms

discussed at option 5) would come into play. But turning to other forms of financing wouldn’t

ameliorate the need for a multilateral platform for dialogue envisaged here. It is also possible

that the digital domaine public payant (or whatever scheme is arrived at, in terms of financing

the envisaged multilateral fund) could be a temporary measure, if a trust fund mechanism was

established which could eventually be self-sustaining if properly funded in the first instance.

ii) What sort of mechanism would payment be made to? How it would be disbursed?

Our clear preference here is for payment to be made to a multilateral fund (option 5) and

disbursed in accordance with the objectives of the CBD and the contributions to multiple SDGs.

There would be no attempt to track and trace with the focus of disbursement upon supporting

projects which serve the objectives of the CBD. This would accordingly extend the ABS

principles underpinning the CBD in respect of DSI to a collective multilateral fund (option 5

above) entrusted with management of monetary benefit sharing.297 This would not involve

countries renouncing sovereignty, but could in some ways reaffirm it,298 while at the same time

moving away from the commercial, bilateral logic of the CBD by recognising the difficulties

associated with the operation of the current ABS approach to DSI.299 In essence, payment to

and disbursement from a multilateral fund, taking into account the lessons from our analysis in

option 5 would resolve the issues of valuation previously identified as so problematic (options

1 to 3) in the context of DSI and help to ensure achievement of the objectives of the CBD.

c) The centrality of the CBD

Finally, we would recommend that the hybrid approach be developed under the CBD

(developing further our discussion under option 5 above), to rely on the existing structure under

the Treaty. Notably, it is the CBD that provides the objectives and international obligations to

guide the exercise and also enjoys – almost – universal membership. It is also flexible enough

to adapt to the demands of other international regimes. Compared to other international treaties,

the CBD is already remarkably open to inputs and engagement with a variety of stakeholders

and the hybrid proposal would mark a step-change in that connection to ensure that the treaty

remains effective and adapted to the evolution of conservation science. While the Nagoya

Protocol could offer an avenue under its Article 10, there are clear disadvantages to this option

297 For discussion in the context of the arts, see Dietz 1990 (supra, n 155), 20. For discussion within the context

of traditional knowledge, see Ruiz Muller 2013 (supra, n 154). 298 In a similar vein, Ruiz Muller 2010 (supra, n 17) 12. 299 See general discussion in ibid, 10. See also Ruiz Muller 2013 (supra, n 154) for discussion in the context of

TK.

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due to, among other things, the limited membership of the Protocol. The CBD already contains

a series of broad obligations that can underpin international cooperation on DSI, notably the

combined reading of the obligations under:

Article 12(c) on research and training for “Parties, taking into account the special

needs of developing countries [to] in keeping with the provisions of Articles 16, 18

and 20, promote and cooperate in the use of scientific advances in biological diversity

research in developing methods for conservation and sustainable use of biological

resources.”; and

Article 17 on the exchange of information, whereby Parties “shall facilitate the

exchange of information, from all publicly available sources, relevant to the

conservation and sustainable use of biological diversity, taking into account the special

needs of developing countries” and “such exchange of information shall include

exchange of results of technical, scientific and socio-economic research, as well as

information on training and surveying programmes, specialized knowledge,

indigenous and traditional knowledge as such and in combination with the

technologies.”

Articles 16 on technology transfer, 18 on technical and scientific cooperation and 20 on

financing are also relevant to the implementation of the CBD Article 15 on ABS, notably

Article 15(7) whereby each Party “shall take legislative, administrative or policy

measures…with the aim of sharing in a fair and equitable way the results of research and

development and the benefits arising from the commercial and other utilization of genetic

resources with the Party providing such resources”, as well as Article 15(6) whereby each Party

“shall endeavour to develop and carry out scientific research based on genetic resources

provided by other Contracting Parties with the full participation of, and where possible in, such

Contracting Parties.”

These provisions can also contribute to the implementation of the Nagoya Protocol, the

preamble to which underscores, that Parties “recogniz[e] the important contribution to

sustainable development made by technology transfer and cooperation to build research and

innovation capacities for adding value to genetic resources in developing countries, in

accordance with Articles 16 and 19 of the Convention.”

Two key questions would, however, remain to be addressed: the relevance of a hybrid approach

for databases in the US and the opportunity for the BBNJ process to link a new international

legally binding instrument to an external platform. It can be hypothesized that if the hybrid

approach creates a useful and fruitful dynamic of cooperation with database operators and

scientists, it will be of interest to US database operators and scientists, as well as of BBNJ-

related database operators and scientists to participate in its process and remain connected with

the rest of the global scientific community. In this regard, and as discussed above (option 5

and 6), offering such a shared space to different actors with differing worldviews, may allow

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for normative transformation300 and allow for new responses to be garnered to deal with

common issues.

Normative transformation in this domain are not a pipe dream and indeed, we can see an

example of such transformational change in the creation of the Global Initiative on Sharing All

Influenza Data (GISAID). This Initiative is the result of much by way of international effort to

create, “consensus on a novel (flu virus) sharing mechanism enabling public and animal health

authorities to continue their surveillance work.”301 The effort to conclude GISAID involved

considerable engagement with a range of actors such as data providers and researchers, as well

as requiring mediation of diplomatic tensions arising from the sharing of such data.302

More fundamentally, even in the absence of the type of normative transformation, research on

regime interactions has underlined the importance of what may be termed, enabling interplay

management, which focuses upon sharing knowledge, communication and understanding, to

promote learning between regimes.303 In that regard, “a more systematic approach to make

information and knowledge about other relevant institutions and the potential for synergy with

them available holds the promise”304 of enhanced and mutually supportive interactions between

regimes.305 Providing an opportunity for the BBNJ process for a new international legally

binding instrument to connect to the platform we envisage here therefore has its own

advantages in terms of promoting synergies between these already overlapping regimes and

thereby promoting more effective interactions and mutual learning. This would also be in line

with the emerging general international law principle of mutual supportiveness.306

Broad acceptance of the need to prioritize these public policy objectives can be justified on the

basis of the alarming findings on the unprecedented rate of biodiversity loss and its wide-

ranging implications for human well-being, as evidenced in the 2019 Global Assessment of

Biodiversity and Ecosystems Services. The urgency of the global biodiversity crisis also needs

to be fully appreciated from an international human rights law perspective: as authoritatively

clarified by the UN Special Rapporteur on the Human Rights and the Environment in 2017, the

full enjoyment of everyone’s human rights to life, health, food and water depend on healthy

ecosystems and their benefits to people, so the protection and realisation of basic human rights

depend on successful efforts to prevent biodiversity loss.

300 Chon 2013 (supra, n 250) 283. 301 S Elbe and G Buckland-Merrett, ‘Data, disease and diplomacy: GISAID's innovative contribution to global

health’ (2017) 1 Global Challenges 33. 302 Ibid. 303 Oberthür 2009 (supra n 284) 387. 304 Ibid, 383. 305 Morgera, Switzer and Tsioumani 2018 (supra, n 38). See also Switzer, Morgera, Burci and Tsioumani,

‘Biodiversity, pathogen sharing and international law’ In S. Negri (ed.), Environmental Health in International

and EU Law: Current Challenges and Legal Responses (pp. 253-271). London. 306 See generally R Pavoni, 'Mutual Supportiveness as a Principle of Interpretation and Law-Making: A Watershed

for the ‘WTO-and-Competing-Regimes’ Debate?' (2010) 21 European Journal of International Law 649.

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Conclusion

The issue of DSI has been a topic of discussion under the CBD since 2016, and it is expected

to be a critical topic at the CBD COP in 2020. Progress at international level has, however,

been very slow due to technical and political complexities. This study investigated if a sound

and practical solution can be found and presented through EU leadership, to bridge and balance

the interests of developing and developed countries, and contribute to the achievement of the

CBD’s three objectives: biodiversity conservation, sustainable use of biological resources, and

fair and equitable benefit-sharing.

This study presented 7 options to address the matter of DSI:

1. DSI is not covered by the CBD or the Nagoya Protocol;

2. DSI is covered by the CBD and the Nagoya Protocol and no additional measures are

taken;

3. Existing CBD/Nagoya Protocol provisions are complemented by the implementation

of a new track-and-trace system;

4. A copyright-inspired sui generis system is put in place;

5. A multilateral DSI fund is put in place;

6. A broader, principled approach to benefit-sharing is taken through a multilateral,

multifunctional platform, or;

7. A hybrid approach is taken that can clearly respond to the various demands expressed

by various CBD stakeholders, which (in itself) can help pave the way for building trust

and political willingness.

It was found that exclusion of DSI from the scope of the CBD was not a recommended option,

as it was interpreted to be contrary to the principles of international law of effectiveness and

good faith and could undermine legal certainty (option 1). However, it was recognised that

application of existing ABS rules without additional measures is likely to cause adverse effects,

due to problems of valuation and mismatch with current scientific practices (option 2). It was

also found that implementation of a new or improved track-and-trace system would be

insufficient to address these issues, as well as tracking and monitoring the use of DSI (option

3). An innovative approach has therefore been suggested.

A hybrid approach (option 7), combining positive and complementary elements of options 4 –

6 is held to be the preferred option in this regard. At its heart is a multilateral platform for

dialogue, learning, oversight and priority-setting (option 6). A more principled approach to

benefit-sharing for DSI, which tackles the issue ‘from the side’ and focuses on beneficiaries’

agency as a cornerstone for fairness and equity in benefit-sharing, as well as the need for

continuous dialogue and learning across disciplines and sectors, allows for a focus on desirable

outcomes rather than technical obstacles to progress. It also seeks to overcome the false

dichotomy between monetary and non-monetary benefits, by focusing on the need to break

barriers to realization of equity and fairness in benefit-sharing, and by basing itself on dialogue

between beneficiaries. This, however, also raises the matter of financial viability (option 5),

with the preferred option being a multilateral fund. Lessons can be learnt in this regard from

the decision-making processes and governance structures that underpin existing global or

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multilateral funds, notably those that foresee in effective, participatory processes for the

delivery of equity. Moreover, innovative approaches should be explored, notably, a derivative

of copyright-like sui generis approach which we term the digital domaine public payant would

both recognise that DSI should not be treated as a freely exploitable resource, and guarantee a

sustainable and equitable source of funding for the achievement of the platform’s activities in

support of the realization of all the CBD objectives and their contributions to multiple SDGs

and the protection of basic human rights that are dependent on biodiversity.

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Annex Table: Overview of Six Existing Multilateral or Global Funding Mechanisms

Fund Objectives Financing Primary types of funding Procedures

Global

Environment

Facility (GEF)

(World Bank)

To meet the agreed

incremental cost of activities

that generate global

environmental benefits

(GEBs) under five different

focal areas: biodiversity,

climate change mitigation,

land degradation,

international waters,

chemicals and waste.

Contributions

from (39)

donor

countries.

Funding for enabling activities to

prepare a plan or programme for

the purpose of fulfilling

commitments under a Convention.

Financing for the incremental

costs of projects, associated with

transforming a project with

national benefits into one with

global environmental benefits.

Proposals are submitted through

Operational Focal Points (OFPs)

or by country governments.

Proposals are submitted to a GEF

agency or to the GEF secretariat,

which provides provisional

approval of individual projects.

Submitted to The Council, which

adopts the overall programme of

work by consensus. The Council

has 32 members (14 from

developed countries; 16 from

developing countries; 2 from

economies in transitions).

The work is supported by the

Scientific and Technical Advisory

Panel (STAP).

ITPGRFA’s

Benefit-Sharing

Fund (BSF)

(FAO)

Objectives of the ITPGRFA,

with priorities following from

the Global Plan of Action:

information exchange,

technology transfer and

Nett. 0.77%

contribution of

sales of

patented

product OR

Primarily project-based grants

which contribute to the

achievement of the objectives of

the ITPGRFA.

Contracting Parties or any legal or

natural person (e.g. including gene

banks, research institutions,

farmers and farmers’

organisations; regional and

70

capacity-building; managing

and conserving plant genetic

resources on farm; sustainable

use of plant genetic resources.

0.5% of gross

sales.

And voluntary

contributions.

Also funding for the development

and implementation of Strategic

Action Plans.

international organisations) can

submit a proposal.

An independent panel of experts

screens the proposals against

eligibility criteria.

A decision on the application is

made by the Bureau, with 7

members (1 each from Africa,

Asia, Europe, GRULAC, Near

East, North America, South West

Pacific).

Green Climate

Fund (GCF)

(UNFCCC)

To make a significant and

ambitious contribution to the

global efforts towards

attaining the goals set by the

international community to

combat climate change, taking

into account the urgent and

immediate needs of

developing countries that are

particularly vulnerable.

Contributions

from donor

countries.

Project- and programme-based

funding in accordance with

climate change strategies and

plans.

Also loans, grants, equity and

guarantee under private sector

window.

Other support includes the

Readiness and Preparatory

Support Programme, which seeks

to enhance the capacities of NDAs

and direct access entities, through

grants or technical assistance.

Private sector (41%) and public

sector (59%) can submit proposals

through GCF Accredited Entities

(including sub-national, national

or regional organisations,

international entities, and private

sector entities).

Funding decisions are made by

consensus by the Governing

Board, made up of 24 members: 3

from Asia-Pacific States; 3 from

the African States; 3 from Latin

American and the Caribbean; 1

from SIDS; 1 from LDCs; 1 from

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Additionally, GCF has an

extensive capacity-building

programme, focusing on:

institutional capacity-building;

enhancement/creation of an

enabling environment; capacity-

building for the implementation of

adaptation measures;

development of research and

systematic observation, including

meteorological, hydrological and

climatological services;

education, training and awareness

raising.

the developing country Parties not

included in the above; 1 to rotate

between developing countries not

included in the above.

GCF has also dedicated resources

to further development of direct

access

Activities between developing

countries and GEF are streamlined

through National Designated

Authorities (NDAs) who also

nominate entities for

accreditation.

Global Agriculture

and Food Security

Program (GAFSP)

(World Bank)

Five objectives: raising

agricultural productivity;

linking farmers to markets;

reducing risk and

vulnerability; improving non-

farm rural livelihoods;

technical assistance,

institution-building and

capacity development.

Contributions

from donor

countries (6

main donors).

Investment grants for countries

and regional organisations to fill

financial gaps of comprehensive

national agriculture and food

security strategies and investment

plans.

Technical assistance financing for

regional organisations in

partnership with supervising

entities with technical expertise.

Loans, credit guarantees, and

Proposals are submitted through a

public sector window by countries

or regional organisations, or a

private sector window by private

firms or financial institutions.

Proposals are reviewed by the

GAFSP Technical Advisory

Committee. They are approved by

the GAFSP Steering Committee,

with members from the 3 original

donor countries (Canada, Spain,

US) and other donor (including

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equity capital for private sector

firms and financial institutions.

private sector), and at least an

equal number from recipient

countries from Africa and other

regions in the world (currently 16

voting members total).

Processes are coordinated by

GAFSP Coordination Unit. World

Bank holds in trust and

administers funds.

The Global Fund to

Fight AIDS,

Tuberculosis and

Malaria (The

Global Fund)

(Independent)

To attract, leverage and invest

additional resources to end the

epidemics of HIV,

tuberculosis and malaria and

to support attainment of the

Sustainable Development

Goals.

Donor-based:

* 93% from

donor

countries;

* 7% from

private sector,

foundations

and innovative

financing

initiatives.

(RED) label

initiative to

generate

private

funding,

Funding for programme

continuation; tailored funding for

focused portfolios; tailored

funding for national strategic

plans; tailored funding for

transition; a full review of the

previous funding programme.

Funding is organised through a

modular framework with different

‘intervention packages’ and

indicators of success. These

include both programmatic

intervention, capacity-building

and more specific project-based

approaches.

Country Coordination

Mechanisms (CCMs) submit

funding application on behalf of a

country. CMMs include

representatives from all sectors:

multilateral or bilateral agencies,

NGOs, academic institutions,

faith-based organisations, private

sector and people living with the

diseases.

Proposals are first reviewed by a

Technical Review Panel (TRP)

formed by independent, technical

experts, and then by a Grants

Approval Committee with

representatives from the Fund’s

senior management and technical,

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bilateral and multilateral partners.

Funding proposals are approved

by a Board of 20 members, with

equal representation of

implementing and donor countries

and including representatives

from ‘communities’, NGOs and

the private sector.

Gavi – the Vaccine

Alliance

To save children's lives and

protect people's health by

increasing equitable use of

vaccines in lower income

countries, through vaccine and

health system strengthening

programmes.

* Direct

contributions

through grants

and agreements

from donor

governments,

foundations

corporations

and

organisations

(77%)

* Innovative

finance (23%):

The

International

Finance

Facility

(market

financing),

Funding for health system

strengthening programmes (full

portfolio planning) and for

vaccine and/or CCEOP support

(partial portfolio planning).

Proposals are submitted through a

national coordination forum

(Inter-agency Coordinating

Committee, Health Sector

Coordinating Committee or

equivalent body), which include

members from different ministries

and other key immunisation

stakeholders (recommended:

academics, technical advisory

group, national regulatory

authority, private sector

representatives).

Proposals are reviewed by an

Independent Review Committee,

with independent experts in public

health, epidemiology, supply

chain, developmental finance and

74

Gavi Matching

Fund, Loan

Buydown

economics.

Gavi’s Chief Executive Officer

decides on the final grant

application.

The Gavi Board, compromised of

28 members, including

independent individuals,

organisations incl. World Bank,

WHO, UNICEF, developing and

donor countries, and vaccine

industry, is responsible for

strategic direction and

policymaking